Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS) (CAPPS)

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: NCT00135707
Recruitment Status : Completed
First Posted : August 26, 2005
Results First Posted : November 20, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Preeclampsia
Interventions Drug: Dietary Supplement/Vitamins
Drug: Placebo for Vitamin C and Vitamin E
Enrollment 10154
Recruitment Details The trial was conducted from July 2003 through February 2008 at the 16 clinical centers and the independent data coordinating center of the MFMU Network. Gestational age at randomization was between 9 weeks 0 days and 16 weeks 6 days. Women were eligible for inclusion if they had not had a previous pregnancy that lasted beyond 19 weeks 6 days.
Pre-assignment Details Women who were no more than 15 weeks pregnant and who consented to participate in the study were given a supply of placebo and asked to return within 2 weeks. Those who returned, who had taken at least 50% of the placebo they were supposed to have taken, and who still met the eligibility criteria were randomly assigned to receive study drug.
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description Vitamins C & E Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Period Title: Overall Study
Started 5088 5066
Completed 4993 4976
Not Completed 95 90
Reason Not Completed
Lost to Follow-up             94             89
Withdrawal by Subject             0             1
Institutional review board request             1             0
Arm/Group Title Daily Vitamin Supplements Placebo for Vitamins C and E Total
Hide Arm/Group Description 1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery. Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery. Total of all reporting groups
Overall Number of Baseline Participants 5087 5065 10152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5087 participants 5065 participants 10152 participants
23.5  (5.2) 23.5  (5.2) 23.5  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5087 participants 5065 participants 10152 participants
Female
5087
 100.0%
5065
 100.0%
10152
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5087 participants 5065 participants 10152 participants
Black
1268
  24.9%
1295
  25.6%
2563
  25.2%
Hispanic
1602
  31.5%
1566
  30.9%
3168
  31.2%
Other
2217
  43.6%
2204
  43.5%
4421
  43.5%
[1]
Measure Description: Race or ethnic group was self-reported.
Week of pregnancy at randomization  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 5087 participants 5065 participants 10152 participants
13.4  (2.1) 13.4  (2.1) 13.4  (2.1)
<13th week of pregnancy at randomization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5087 participants 5065 participants 10152 participants
2227
  43.8%
2203
  43.5%
4430
  43.6%
Prepregnancy body-mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 5087 participants 5065 participants 10152 participants
25.4  (6.0) 25.4  (5.9) 25.4  (6.0)
[1]
Measure Description: The body-mass index is the weight in kilograms divided by the square of the height in meters. Prepregnancy weight used to calculate body-mass index was self-reported. Values were unavailable for 99 women in the vitamin group and 111 in the placebo group.
Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5087 participants 5065 participants 10152 participants
812
  16.0%
781
  15.4%
1593
  15.7%
Educational level  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 5087 participants 5065 participants 10152 participants
12.8  (2.7) 12.8  (2.7) 12.8  (2.7)
Use of prenatal vitamins or multivitamins  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5087 participants 5065 participants 10152 participants
3903
  76.7%
3889
  76.8%
7792
  76.8%
Daily dose of vitamin C  
Median (Inter-Quartile Range)
Unit of measure:  Mg
Number Analyzed 5087 participants 5065 participants 10152 participants
120
(50 to 120)
100
(50 to 120)
100
(50 to 120)
Daily dose of vitamin E  
Median (Inter-Quartile Range)
Unit of measure:  IU
Number Analyzed 5087 participants 5065 participants 10152 participants
22
(3 to 30)
22
(0 to 30)
22
(2 to 30)
Previous pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5087 participants 5065 participants 10152 participants
1161
  22.8%
1170
  23.1%
2331
  23.0%
Family history of preeclampsia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5087 participants 5065 participants 10152 participants
650
  12.8%
674
  13.3%
1324
  13.0%
[1]
Measure Description: Family history is based on self-reported preeclampsia in a first-degree relative (mother, sister, or grandmother).
Blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 5087 participants 5065 participants 10152 participants
Systolic 109  (10) 109  (10) 109  (9.1)
Diastolic 66  (8) 65  (8) 65  (6.6)
1.Primary Outcome
Title Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate
Hide Description Severe hypertension (blood pressure [BP]>= 160/110) or mild hypertension (BP>= 140/90) >= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent to treat.
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
305
   6.1%
285
   5.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments The primary hypothesis states that antioxidant therapy initiated prior to 16 weeks gestation in women will reduce the frequency of serious maternal and infant complications associated with pregnancy related hypertension. We estimated that with a sample size of 10,000 women, the study would have 90% power to show a 30% reduction in the rate of the primary outcome, from 4% in the placebo to 2.8% in the vitamin group, with a two-sided type I error rate of 5%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.91 to 1.25
Estimation Comments [Not Specified]
2.Primary Outcome
Title Severe Hypertension
Hide Description Included here are women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
210
   4.2%
204
   4.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.85 to 1.24
Estimation Comments [Not Specified]
3.Primary Outcome
Title Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels
Hide Description Elevated liver enzyme levels are specified as an aspartate aminotransferase level of >= 100 U per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
26
   0.5%
33
   0.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.47 to 1.31
Estimation Comments [Not Specified]
4.Primary Outcome
Title Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia
Hide Description Thrombocytopenia defined as a platelet count of <100,000 per cubic millimeter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Number
Unit of Measure: participants
21 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.39 to 1.17
Estimation Comments [Not Specified]
5.Primary Outcome
Title Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level
Hide Description Elevated serum creatinine defined as ≥1.5 mg per deciliter or 132.6 μmol per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
7
   0.1%
11
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.25 to 1.63
Estimation Comments [Not Specified]
6.Primary Outcome
Title Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure
Hide Description Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.2%
4
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.49
Confidence Interval (2-Sided) 95%
0.78 to 7.94
Estimation Comments [Not Specified]
7.Primary Outcome
Title Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders
Hide Description Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
13
   0.3%
16
   0.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.39 to 1.68
Estimation Comments [Not Specified]
8.Primary Outcome
Title Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the 3rd Percentile) Adjusted for Sex and Race or Ethnic Group
Hide Description Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
60
   1.2%
46
   0.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.89 to 1.90
Estimation Comments [Not Specified]
9.Primary Outcome
Title Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death
Hide Description Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Time Frame 20 weeks through discharge or prior to discharge following delivery admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
12
   0.2%
11
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.48 to 2.46
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)
Hide Description HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
Total Preeclampsia
358
   7.2%
332
   6.7%
Mild Preeclampsia
212
   4.2%
191
   3.8%
Severe Preeclampsia
134
   2.7%
129
   2.6%
HELLP Syndrome
2
   0.0%
8
   0.2%
Eclampsia
10
   0.2%
4
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.93 to 1.24
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Pregnancy Associated Hypertension
Hide Description [Not Specified]
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
1457
  29.2%
1322
  26.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
1.03 to 1.17
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Medically Indicated Delivery Because of Hypertension
Hide Description [Not Specified]
Time Frame 20 weeks through discharge following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4952 4934
Measure Type: Count of Participants
Unit of Measure: Participants
509
  10.3%
473
   9.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.95 to 1.21
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Aspartate Aminotransferase ≥100 U/Liter
Hide Description [Not Specified]
Time Frame 20 weeks through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
35
   0.7%
48
   1.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.73
Confidence Interval 95%
0.47 to 1.12
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Creatinine ≥1.5 mg/dl (133 μmol/Liter)
Hide Description [Not Specified]
Time Frame 20 weeks through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
9
   0.2%
12
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.32 to 1.77
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Antepartum Bleeding
Hide Description [Not Specified]
Time Frame During pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4956 4937
Measure Type: Count of Participants
Unit of Measure: Participants
56
   1.1%
46
   0.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.82 to 1.79
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Premature Rupture of Membranes
Hide Description [Not Specified]
Time Frame During pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4934 4923
Measure Type: Count of Participants
Unit of Measure: Participants
124
   2.5%
129
   2.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.75 to 1.22
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Placental Abruption
Hide Description [Not Specified]
Time Frame During pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4957 4938
Measure Type: Count of Participants
Unit of Measure: Participants
24
   0.5%
36
   0.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.40 to 1.11
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Cesarean Delivery
Hide Description [Not Specified]
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4958 4940
Measure Type: Count of Participants
Unit of Measure: Participants
1269
  25.6%
1224
  24.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.97 to 1.11
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Maternal Death
Hide Description [Not Specified]
Time Frame Delivery through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
One maternal death in each group due to peripartum cardiomyopathy.
Arm/Group Title Dietary Supplement/Vitamins Placebo for Vitamin C and Vitamin E
Hide Arm/Group Description:

1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.

Dietary Supplement/Vitamins: Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery.

Placebo for Vitamin C and Vitamin E: Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.0%
1
   0.0%
20.Secondary Outcome
Title Postpartum Pulmonary Edema
Hide Description [Not Specified]
Time Frame After delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4951 4926
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.1%
10
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.08 to 1.08
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Hematocrit ≤24% With Transfusion
Hide Description [Not Specified]
Time Frame Delivery admission to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4954 4927
Measure Type: Count of Participants
Unit of Measure: Participants
40
   0.8%
59
   1.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.45 to 1.01
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Maternal Hospital Stay
Hide Description [Not Specified]
Time Frame Delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4952 4935
Median (Inter-Quartile Range)
Unit of Measure: days
2.0
(2.0 to 3.0)
2.0
(2.0 to 3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
23.Secondary Outcome
Title Gestational Age at Delivery
Hide Description [Not Specified]
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Median (Standard Deviation)
Unit of Measure: weeks
38.9  (3.5) 38.8  (3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
24.Secondary Outcome
Title Preterm Birth
Hide Description [Not Specified]
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
<37 weeks' gestation
513
  10.3%
526
  10.6%
<32 weeks' gestation
149
   3.0%
173
   3.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments <37 weeks' gestation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.87 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments <32 weeks' gestation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.69 to 1.06
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Fetal or Neonatal Death
Hide Description [Not Specified]
Time Frame During pregnancy or thorugh discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4993 4976
Measure Type: Count of Participants
Unit of Measure: Participants
All Fetal or Neonatal Deaths
113
   2.3%
122
   2.5%
Fetal loss at < 20 weeks
55
   1.1%
59
   1.2%
Fetal death at ≥20 weeks
38
   0.8%
36
   0.7%
Neonatal death
20
   0.4%
27
   0.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.72 to 1.19
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Birth Weight
Hide Description [Not Specified]
Time Frame At birth
Hide Outcome Measure Data
Hide Analysis Population Description
Liveborn infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Mean (Standard Deviation)
Unit of Measure: grams
3247  (575) 3244  (581)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
27.Secondary Outcome
Title Small for Gestational Age
Hide Description A baby whose birth weight is less than the 3rd percentile is considered to be small for gestational age (adjusted for sex and race or ethnic group)
Time Frame At birth
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
133
   2.7%
132
   2.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.79 to 1.27
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Birth Weight <2500 Grams
Hide Description [Not Specified]
Time Frame At birth
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
345
   7.0%
369
   7.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.81 to 1.07
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Admission to NICU
Hide Description NICU denotes neonatal intensive care unit.
Time Frame Delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
577
  11.8%
557
  11.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.92 to 1.15
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Respiratory Distress Syndrome
Hide Description [Not Specified]
Time Frame Delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
150
   3.1%
144
   3.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.83 to 1.30
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Intraventricular Hemorrhage, Grade III or IV
Hide Description [Not Specified]
Time Frame Delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
6
   0.1%
7
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.29 to 2.54
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Sepsis
Hide Description [Not Specified]
Time Frame Delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
30
   0.6%
23
   0.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.76 to 2.23
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Necrotizing Enterocolitis
Hide Description [Not Specified]
Time Frame Delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.2%
14
   0.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.32 to 1.60
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Retinopathy of Prematurity
Hide Description [Not Specified]
Time Frame Within 1 month of birth
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Count of Participants
Unit of Measure: Participants
19
   0.4%
16
   0.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.61 to 2.30
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Apgar Score <=3 at 5 Minutes
Hide Description [Not Specified]
Time Frame At birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Measure Type: Number
Unit of Measure: participants
23 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.49 to 1.48
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Neonatal Hospital Stay
Hide Description [Not Specified]
Time Frame Birth through discharge from hospital
Hide Outcome Measure Data
Hide Analysis Population Description
Live born infants
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 4900 4881
Median (Inter-Quartile Range)
Unit of Measure: days
2.0
(2.0 to 3.0)
2.0
(2.0 to 3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
37.Post-Hoc Outcome
Title Analysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy
Hide Description Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized on or after the 13th week of pregnancy.
Time Frame During pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:

1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.

Dietary Supplement/Vitamins: Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery.

Placebo for Vitamin C and Vitamin E: Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

Overall Number of Participants Analyzed 2812 2814
Measure Type: Count of Participants
Unit of Measure: Participants
161
   5.7%
158
   5.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.82 to 1.26
Estimation Comments [Not Specified]
38.Post-Hoc Outcome
Title Analysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy
Hide Description Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized before the 13th week of pregnancy.
Time Frame During pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description:
Vitamins C & E
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Overall Number of Participants Analyzed 2181 2162
Measure Type: Count of Participants
Unit of Measure: Participants
144
   6.6%
127
   5.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamins, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.89 to 1.42
Estimation Comments [Not Specified]
Time Frame Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamins Placebo
Hide Arm/Group Description Vitamins C & E Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
All-Cause Mortality
Vitamins Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/5087 (0.02%)   1/5065 (0.02%) 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamins Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   108/5087 (2.12%)   173/5065 (3.42%) 
Blood and lymphatic system disorders     
Hodgkin's disease *  1/5087 (0.02%)  0/5065 (0.00%) 
Infant low platelet count   1/5087 (0.02%)  0/5065 (0.00%) 
Cardiac disorders     
Peripartum Cardiomyopathy * [1]  1/5087 (0.02%)  1/5065 (0.02%) 
Cardiomyopathy *  0/5087 (0.00%)  1/5065 (0.02%) 
Congenital, familial and genetic disorders     
Fetal birth defects *  6/5087 (0.12%)  21/5065 (0.41%) 
Fetal atrial flutter/arrythmia/bradycardia *  2/5087 (0.04%)  1/5065 (0.02%) 
General disorders     
Neonatal death *  20/5087 (0.39%)  27/5065 (0.53%) 
Infections and infestations     
Infection * [2]  5/5087 (0.10%)  2/5065 (0.04%) 
Injury, poisoning and procedural complications     
Birth injury   1/5087 (0.02%)  1/5065 (0.02%) 
Musculoskeletal and connective tissue disorders     
Umbilical hernia   0/5087 (0.00%)  1/5065 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Infant - Soft Tissue Mass   1/5087 (0.02%)  0/5065 (0.00%) 
Nervous system disorders     
Infant Seizures   2/5087 (0.04%)  0/5065 (0.00%) 
Hypoxic Events  [3]  2/5087 (0.04%)  0/5065 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Fetal Death * [4]  45/5087 (0.88%)  95/5065 (1.88%) 
Bleeding * [5]  9/5087 (0.18%)  7/5065 (0.14%) 
Hemorrhage * [6]  4/5087 (0.08%)  5/5065 (0.10%) 
Renal and urinary disorders     
Renal and Urinary disorders * [7]  4/5087 (0.08%)  9/5065 (0.18%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory distress/pneumonia *  1/5087 (0.02%)  1/5065 (0.02%) 
DVT/PE * [8]  2/5087 (0.04%)  1/5065 (0.02%) 
Surgical and medical procedures     
Colon resection *  1/5087 (0.02%)  0/5065 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
[1]
Peripartum Cardiomyopathy resulting in death.
[2]
Group A strep sepsis, bacterial/ viral meningitis, cellulitis, sepsis, bacterial infection
[3]
Hypoxic birth injury, hypoxic ischemic encephalopathy, ischemic stroke
[4]
Miscarriage, stillbirth, abortion
[5]
Placental abruption, vaginal bleeding
[6]
Postpartum hemorrhage, blood transfusion, hysterectomy
[7]
Pyelonephritis and Urinary Tract Infection
[8]
Deep vein thrombosis, pulmonary embolism
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vitamins Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5087 (0.00%)   0/5065 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. James Roberts
Organization: Dept of Obstetrics and Gynecology, University of Pittsburgh
Phone: 412-641-1427
EMail: RSIJMR@mwri.magee.edu
Other Publications:
Layout table for additonal information
Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00135707     History of Changes
Other Study ID Numbers: HD36801-CAPPS
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD027860 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD034136 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U01HD036801 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD053118 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2005
First Posted: August 26, 2005
Results First Submitted: November 1, 2012
Results First Posted: November 20, 2018
Last Update Posted: February 21, 2019