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Chloroquine for Malaria in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01443130
Recruitment Status : Completed
First Posted : September 29, 2011
Results First Posted : October 29, 2015
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Malaria
Interventions Drug: Chloroquine
Drug: Sulfadoxine-pyrimethamine
Enrollment 900
Recruitment Details Participants were pregnant women in their first or second pregnancy recruited during presentation at the Ndirande Antenatal Clinic (ANC) at the Ndirande Health Centre, enrolled between 22 February 2012 and 16 May 2014.
Pre-assignment Details The infants born to these participants were also enrolled in the study to be assessed at birth and followed to 14 weeks. The infants are reported here as separate arms of the study, grouped by the study product given to the mother.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Hide Arm/Group Description Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery. Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. Infants born to maternal participants who received chloroquine prophylaxis. Infants born to maternal participants who received chloroquine IPT. Infants born to maternal participants who received SP IPT.
Period Title: Overall Study
Started 300 300 300 270 274 259
Completed 232 231 223 231 230 225
Not Completed 68 69 77 39 44 34
Reason Not Completed
Lost to Follow-up             44             42             50             23             25             21
Death             0             1             0             7             10             8
Adverse Event             2             1             1             0             0             0
Protocol Violation             2             1             3             2             2             3
Withdrawal by Subject             15             14             12             7             7             2
Death of Subject's Infant             5             10             11             0             0             0
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT Total
Hide Arm/Group Description Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery. Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. Infants born to maternal participants who received chloroquine prophylaxis. Infants born to maternal participants who received chloroquine IPT. Infants born to maternal participants who received SP IPT. Total of all reporting groups
Overall Number of Baseline Participants 300 300 300 270 274 259 1703
Hide Baseline Analysis Population Description
All participants enrolled in the study are included in the baseline analysis population, with the exception of the age continuous for all groups, which is limited to the maternal participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 300 participants 270 participants 274 participants 259 participants 1703 participants
<=18 years
99
  33.0%
81
  27.0%
90
  30.0%
270
 100.0%
274
 100.0%
259
 100.0%
1073
  63.0%
Between 18 and 65 years
201
  67.0%
219
  73.0%
210
  70.0%
0
   0.0%
0
   0.0%
0
   0.0%
630
  37.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 300 participants 300 participants 300 participants 270 participants 274 participants 259 participants 1703 participants
20.40  (3.59) 20.67  (3.24) 20.44  (3.14) 0  (0) 0  (0) 0  (0) 20.50  (3.33)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 300 participants 270 participants 274 participants 259 participants 1703 participants
Female
300
 100.0%
300
 100.0%
300
 100.0%
133
  49.3%
143
  52.2%
136
  52.5%
1312
  77.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
137
  50.7%
131
  47.8%
123
  47.5%
391
  23.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malawi Number Analyzed 300 participants 300 participants 300 participants 270 participants 274 participants 259 participants 1703 participants
300 300 300 270 274 259 1703
1.Primary Outcome
Title Incidence of Placental Malaria Infection Based on Histology
Hide Description The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 259 253 253
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of pregnancies
11.58
(7.52 to 16.80)
15.42
(10.67 to 21.21)
15.42
(10.67 to 21.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2441
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Placental Malaria by Placental Impression Smear
Hide Description Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 259 254 253
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of placentas
0
(0.00 to 1.68)
0
(0.00 to 1.71)
0.40
(0.00 to 2.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4941
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4990
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)
Hide Description Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL).
Time Frame From enrollment until delivery, approximately 12-36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all maternal participants.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 300 300 300
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of maternal participants
18.3
(13.58 to 23.89)
23.7
(18.36 to 29.64)
22.0
(16.85 to 27.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3089
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6973
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)
Hide Description Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl.
Time Frame From enrollment until delivery, approximately 12-36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all maternal participants.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 300 300 300
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of maternal participants
0.0
(0.00 to 1.45)
0.3
(0.00 to 2.11)
0.3
(0.00 to 2.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Incidence of Stillbirth
Hide Description Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants whose pregnancies were followed to delivery.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 272 273 263
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of deliveries
1.10
(0.17 to 3.54)
0.37
(0.00 to 2.31)
1.90
(0.52 to 4.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4979
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1166
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Incidence of Miscarriage
Hide Description Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all maternal participants.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 300 300 300
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of pregnancies
0.33
(0 to 2.11)
0.67
(0.06 to 2.68)
1.00
(0.16 to 3.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6237
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Incidence of Preterm Delivery
Hide Description Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants whose pregnancies were followed to delivery.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 272 273 263
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of deliveries
8.46
(5.08 to 13.02)
9.89
(6.23 to 14.69)
6.84
(3.80 to 11.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5187
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2163
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Infant Mortality Rate to 14 Weeks of Age
Hide Description Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery.
Time Frame For 14 weeks after delivery.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all enrolled infants.
Arm/Group Title Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Hide Arm/Group Description:
Infants born to maternal participants who received chloroquine prophylaxis.
Infants born to maternal participants who received chloroquine IPT.
Infants born to maternal participants who received SP IPT.
Overall Number of Participants Analyzed 270 274 259
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of infants
2.22
(0.70 to 5.18)
3.65
(1.58 to 7.07)
3.09
(1.18 to 6.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infant Chloroquine Prophylaxis, Infant SP IPT
Comments The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5959
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infant Chloroquine IPT, Infant SP IPT
Comments The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8127
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)
Hide Description Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all infants born alive with weight data collected at birth.
Arm/Group Title Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Hide Arm/Group Description:
Infants born to maternal participants who received chloroquine prophylaxis.
Infants born to maternal participants who received chloroquine IPT.
Infants born to maternal participants who received SP IPT.
Overall Number of Participants Analyzed 263 264 256
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of infants
15.59
(10.91 to 21.28)
10.98
(7.06 to 16.05)
12.11
(7.93 to 17.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infant Chloroquine Prophylaxis, Infant SP IPT
Comments The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2566
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infant Chloroquine IPT, Infant SP IPT
Comments The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7839
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Incidence of Intrauterine Growth Restriction (IUGR)
Hide Description Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery.
Arm/Group Title Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Hide Arm/Group Description:
Infants born to maternal participants who received chloroquine prophylaxis.
Infants born to maternal participants who received chloroquine IPT.
Infants born to maternal participants who received SP IPT.
Overall Number of Participants Analyzed 260 261 250
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
16.54
(11.70 to 22.37)
18.01
(12.98 to 23.98)
20.80
(15.32 to 27.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infant Chloroquine Prophylaxis, Infant SP IPT
Comments The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2553
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infant Chloroquine IPT, Infant SP IPT
Comments The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4354
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Incidence of Active Placental Malaria Infection
Hide Description Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR).
Time Frame At delivery: Approximately 12-36 weeks after enrollment
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Hide Analysis Population Description
This analysis population includes all maternal subjects with placental slides reviewed and PCR results obtained.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 259 253 253
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
3.09
(1.18 to 6.46)
3.16
(1.21 to 6.61)
4.74
(2.24 to 8.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3690
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4947
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Incidence of Malaria Infection, All Species.
Hide Description Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects.
Time Frame Enrollment to delivery (approximately 12-36 weeks)
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Hide Analysis Population Description
The analysis population includes all maternal participants.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 300 300 300
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
0.67
(0.06 to 2.68)
1.67
(0.45 to 4.20)
3.00
(1.22 to 6.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0630
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4184
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Incidence of Clinical Malaria, All Species
Hide Description Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness.
Time Frame Enrollment to delivery (approximately 12-36 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all maternal participants.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 300 300 300
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
0.67
(0.53 to 4.89)
1.33
(0.97 to 6.09)
3.00
(0.07 to 3.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0268
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Cox proportional hazards
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1646
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Cox proportional hazards
Comments [Not Specified]
14.Secondary Outcome
Title Incidence of Infection in the Fetal Circulation
Hide Description Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample.
Time Frame At delivery: Approximately 12-36 weeks after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all maternal participants with cord blood smears and cord PCR results obtained.
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT
Hide Arm/Group Description:
Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
Overall Number of Participants Analyzed 257 252 251
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
1.95
(0.53 to 4.89)
2.78
(0.97 to 6.09)
0.80
(0.07 to 3.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine Prophylaxis, Maternal SP IPT
Comments The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4501
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maternal Chloroquine IPT, Maternal SP IPT
Comments The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1758
Comments A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Hide Arm/Group Description Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery. Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. Infants born to maternal participants who received chloroquine prophylaxis. Infants born to maternal participants who received chloroquine IPT. Infants born to maternal participants who received SP IPT.
All-Cause Mortality
Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/300 (7.67%)      29/300 (9.67%)      26/300 (8.67%)      46/270 (17.04%)      65/274 (23.72%)      43/259 (16.60%)    
Blood and lymphatic system disorders             
Anaemia * 1  1/300 (0.33%)  1 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Anaemia of pregnancy * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Cardiac disorders             
Cardio-respiratory arrest * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Congenital, familial and genetic disorders             
Accessory auricle * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Dermoid cyst * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Heart disease congenital * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Laryngomalacia * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 1/274 (0.36%)  2 1/259 (0.39%)  1
Polydactyly * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 6/270 (2.22%)  6 9/274 (3.28%)  9 6/259 (2.32%)  6
Talipes * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 2/274 (0.73%)  2 0/259 (0.00%)  0
Umbilical cord haemorrhage * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Gastrointestinal disorders             
Constipation * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
General disorders             
Death neonatal * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Pyrexia * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 2/274 (0.73%)  2 2/259 (0.77%)  2
Sudden infant death syndrome * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 2/274 (0.73%)  2 0/259 (0.00%)  0
Hepatobiliary disorders             
Hyperbilirubinaemia * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 1/274 (0.36%)  1 1/259 (0.39%)  1
Infections and infestations             
Bartholin's abscess * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Dysentery * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Gastroenteritis * 1  1/300 (0.33%)  1 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Incision site infection * 1  1/300 (0.33%)  1 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Malaria * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Peritonitis * 1  1/300 (0.33%)  1 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Pneumonia * 1  1/300 (0.33%)  1 0/300 (0.00%)  0 0/300 (0.00%)  0 2/270 (0.74%)  2 3/274 (1.09%)  3 0/259 (0.00%)  0
Postoperative wound infection * 1  0/300 (0.00%)  0 2/300 (0.67%)  2 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Postpartum sepsis * 1  2/300 (0.67%)  2 0/300 (0.00%)  0 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Urinary tract infection * 1  3/300 (1.00%)  3 1/300 (0.33%)  1 4/300 (1.33%)  4 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Wound infection * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Abscess * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Bronchiolitis * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 5/270 (1.85%)  5 4/274 (1.46%)  4 1/259 (0.39%)  1
Group B streptococcus neonatal sepsis * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Pneumocystis jirovecii pneumonia * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 2/270 (0.74%)  2 0/274 (0.00%)  0 0/259 (0.00%)  0
Sepsis * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 2/274 (0.73%)  2 0/259 (0.00%)  0
Sepsis neonatal * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 6/270 (2.22%)  6 10/274 (3.65%)  10 12/259 (4.63%)  12
Staphylococcal sepsis * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Upper respiratory tract infection * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 2/270 (0.74%)  2 0/274 (0.00%)  0 0/259 (0.00%)  0
Metabolism and nutrition disorders             
Failure to thrive * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 2/270 (0.74%)  2 0/274 (0.00%)  0 0/259 (0.00%)  0
Feeding disorder neonatal * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 1/259 (0.39%)  1
Marasmus * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Muscular weakness * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Haemangioma * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Nervous system disorders             
Hypoxic-ischaemic encephalopathy * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 2/259 (0.77%)  2
Myoclonus * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Abortion incomplete * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Abortion spontaneous * 1  1/300 (0.33%)  1 1/300 (0.33%)  1 2/300 (0.67%)  2 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Abortion threatened * 1  1/300 (0.33%)  1 2/300 (0.67%)  2 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Eclampsia * 1  3/300 (1.00%)  3 3/300 (1.00%)  3 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Foetal death * 1  3/300 (1.00%)  3 1/300 (0.33%)  1 4/300 (1.33%)  4 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Gestational hypertension * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Haemorrhage in pregnancy * 1  1/300 (0.33%)  2 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Postpartum haemorrhage * 1  1/300 (0.33%)  1 1/300 (0.33%)  1 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Pre-eclampsia * 1  1/300 (0.33%)  1 2/300 (0.67%)  2 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Premature delivery * 1  2/300 (0.67%)  2 0/300 (0.00%)  0 1/300 (0.33%)  1 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
Premature labour * 1  2/300 (0.67%)  2 6/300 (2.00%)  6 5/300 (1.67%)  5 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Premature rupture of membranes * 1  1/300 (0.33%)  1 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Preterm premature rupture of membranes * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Prolonged rupture of membranes * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Stillbirth * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Uterine contractions during pregnancy * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 1/300 (0.33%)  1 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Jaundice neonatal * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Low birth weight baby * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 2/274 (0.73%)  2 1/259 (0.39%)  1
Premature baby * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 5/270 (1.85%)  5 9/274 (3.28%)  9 2/259 (0.77%)  2
Psychiatric disorders             
Brief psychotic disorder, with postpartum onset * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Psychotic disorder * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Reproductive system and breast disorders             
Vaginal haemorrhage * 1  0/300 (0.00%)  0 1/300 (0.33%)  1 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Aspiration * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Neonatal asphyxia * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 6/270 (2.22%)  6 2/274 (0.73%)  2 8/259 (3.09%)  8
Neonatal aspiration * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 2/274 (0.73%)  2 1/259 (0.39%)  1
Neonatal respiratory distress syndrome * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 3/274 (1.09%)  3 3/259 (1.16%)  3
Respiratory arrest * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 0/274 (0.00%)  0 1/259 (0.39%)  1
Respiratory distress * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 2/274 (0.73%)  2 3/259 (1.16%)  3
Transient tachypnoea of the newborn * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 6/274 (2.19%)  6 3/259 (1.16%)  3
Skin and subcutaneous tissue disorders             
Melanosis * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Surgical and medical procedures             
Vacuum extractor delivery * 1  0/300 (0.00%)  0 0/300 (0.00%)  0 0/300 (0.00%)  0 1/270 (0.37%)  1 0/274 (0.00%)  0 0/259 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maternal Chloroquine Prophylaxis Maternal Chloroquine IPT Maternal SP IPT Infant Chloroquine Prophylaxis Infant Chloroquine IPT Infant SP IPT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   255/300 (85.00%)      251/300 (83.67%)      234/300 (78.00%)      195/270 (72.22%)      186/274 (67.88%)      171/259 (66.02%)    
Blood and lymphatic system disorders             
Anaemia * 1  12/300 (4.00%)  14 20/300 (6.67%)  21 17/300 (5.67%)  17 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Cardiac disorders             
Palpitations * 1  16/300 (5.33%)  16 19/300 (6.33%)  21 8/300 (2.67%)  8 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Eye disorders             
Conjunctivitis * 1  3/300 (1.00%)  3 1/300 (0.33%)  1 7/300 (2.33%)  7 22/270 (8.15%)  22 27/274 (9.85%)  28 17/259 (6.56%)  17
Gastrointestinal disorders             
Abdominal pain * 1  78/300 (26.00%)  92 73/300 (24.33%)  90 62/300 (20.67%)  77 4/270 (1.48%)  4 2/274 (0.73%)  2 2/259 (0.77%)  2
Diarrhoea * 1  36/300 (12.00%)  39 28/300 (9.33%)  29 16/300 (5.33%)  17 9/270 (3.33%)  9 6/274 (2.19%)  6 5/259 (1.93%)  5
Nausea * 1  3/300 (1.00%)  3 17/300 (5.67%)  20 2/300 (0.67%)  2 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Vomiting * 1  32/300 (10.67%)  37 63/300 (21.00%)  75 16/300 (5.33%)  17 3/270 (1.11%)  3 6/274 (2.19%)  6 4/259 (1.54%)  4
General disorders             
Pain * 1  16/300 (5.33%)  18 26/300 (8.67%)  30 21/300 (7.00%)  21 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Pyrexia * 1  7/300 (2.33%)  8 13/300 (4.33%)  14 6/300 (2.00%)  6 18/270 (6.67%)  19 15/274 (5.47%)  15 12/259 (4.63%)  12
Infections and infestations             
Gastroenteritis * 1  20/300 (6.67%)  23 10/300 (3.33%)  12 18/300 (6.00%)  19 9/270 (3.33%)  10 9/274 (3.28%)  9 3/259 (1.16%)  3
Tonsillitis * 1  23/300 (7.67%)  25 12/300 (4.00%)  13 12/300 (4.00%)  15 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Upper respiratory tract infection * 1  90/300 (30.00%)  113 65/300 (21.67%)  70 73/300 (24.33%)  82 136/270 (50.37%)  172 124/274 (45.26%)  154 118/259 (45.56%)  152
Urinary tract infection * 1  25/300 (8.33%)  29 27/300 (9.00%)  28 27/300 (9.00%)  28 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Vulvovaginal candidiasis * 1  11/300 (3.67%)  13 17/300 (5.67%)  18 13/300 (4.33%)  14 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Bronchiolitis * 1  1/300 (0.33%)  1 0/300 (0.00%)  0 0/300 (0.00%)  0 10/270 (3.70%)  10 7/274 (2.55%)  7 17/259 (6.56%)  18
Impetigo * 1  1/300 (0.33%)  1 0/300 (0.00%)  0 0/300 (0.00%)  0 4/270 (1.48%)  4 3/274 (1.09%)  3 14/259 (5.41%)  15
Nasopharyngitis * 1  15/300 (5.00%)  15 7/300 (2.33%)  7 15/300 (5.00%)  15 18/270 (6.67%)  19 19/274 (6.93%)  19 18/259 (6.95%)  18
Pneumonia * 1  12/300 (4.00%)  13 5/300 (1.67%)  5 4/300 (1.33%)  4 8/270 (2.96%)  8 15/274 (5.47%)  15 11/259 (4.25%)  11
Respiratory tract infection * 1  13/300 (4.33%)  13 6/300 (2.00%)  6 4/300 (1.33%)  4 19/270 (7.04%)  19 29/274 (10.58%)  31 17/259 (6.56%)  18
Rhinitis * 1  12/300 (4.00%)  12 8/300 (2.67%)  8 14/300 (4.67%)  16 15/270 (5.56%)  16 16/274 (5.84%)  16 12/259 (4.63%)  13
Skin bacterial infection * 1  2/300 (0.67%)  2 0/300 (0.00%)  0 1/300 (0.33%)  1 22/270 (8.15%)  25 15/274 (5.47%)  15 19/259 (7.34%)  19
Investigations             
Blood pressure increased * 1  12/300 (4.00%)  12 12/300 (4.00%)  12 20/300 (6.67%)  20 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain * 1  21/300 (7.00%)  25 19/300 (6.33%)  21 16/300 (5.33%)  16 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Musculoskeletal pain * 1  79/300 (26.33%)  88 75/300 (25.00%)  95 56/300 (18.67%)  70 0/270 (0.00%)  0 1/274 (0.36%)  1 0/259 (0.00%)  0
Nervous system disorders             
Dizziness * 1  16/300 (5.33%)  16 62/300 (20.67%)  75 12/300 (4.00%)  12 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Headache * 1  88/300 (29.33%)  113 76/300 (25.33%)  96 76/300 (25.33%)  89 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Gestational hypertension * 1  24/300 (8.00%)  24 28/300 (9.33%)  28 26/300 (8.67%)  27 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Prolonged labour * 1  20/300 (6.67%)  20 25/300 (8.33%)  25 22/300 (7.33%)  22 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Renal and urinary disorders             
Proteinuria * 1  11/300 (3.67%)  11 24/300 (8.00%)  24 15/300 (5.00%)  15 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
Vascular disorders             
Hypotension * 1  12/300 (4.00%)  15 20/300 (6.67%)  24 12/300 (4.00%)  16 0/270 (0.00%)  0 0/274 (0.00%)  0 0/259 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
The observed placental malaria rate was lower than expected causing the study to be under powered. After review of a futility analysis, the Sponsor and DSMB recommended allowing the study to conclude as planned and not to increase the sample size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Miriam K. Laufer, MD, MPH
Organization: University of Maryland School of Medicine
Phone: 410-706-5333
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01443130     History of Changes
Other Study ID Numbers: 09-0112
4R01AI104702-04 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2011
First Posted: September 29, 2011
Results First Submitted: October 1, 2015
Results First Posted: October 29, 2015
Last Update Posted: December 28, 2016