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KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section (KBTH-HBWS)

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: NCT03062228
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
Korle Bu Teaching Hospital
University of Michigan
Innovative Canadians for Change
Dalhousie University
Global Innovations for Reproductive Health & Life
University of Ghana Medical School
Information provided by (Responsible Party):
Allan Kember, IWK Health Centre

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions Infant, Small for Gestational Age
Infant, Low Birth Weight
Pregnancy
Sleep
Infant, Very Low Birth Weight
Fetal Growth Retardation
Enrollment 162
Recruitment Details Participants were recruited between April 28 2016 through February 22 2017, inclusive. Participants were recruited by the study recruiter from a sample of healthy, Ghanaian women presenting to the KBTH maternity wards and who delivered a live birth within the past 48 hours.
Pre-assignment Details There were no significant events in the study after participant enrollment but prior to assignment to an arm or group. Two participants who were recruited were excluded from the study after it was discovered later that they did not fully meet the eligibility criteria (both had delivered stillborn infants).
Arm/Group Title Controls
Hide Arm/Group Description

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Period Title: Overall Study
Started 162
Completed 162
Not Completed 0
Arm/Group Title Controls
Hide Arm/Group Description

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Baseline Participants 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
28.7  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Female
162
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ghanaian Number Analyzed 162 participants
162
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Ghana Number Analyzed 162 participants
162
 100.0%
Gravidity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Gravida 1
33
  20.4%
Gravida ≥2
129
  79.6%
Parity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Para 1
44
  27.2%
Para ≥2
118
  72.8%
Education level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Tertiary
21
  13.0%
Vocational
1
   0.6%
Senior High
52
  32.1%
Junior High
57
  35.2%
Primary
30
  18.5%
Undisclosed
1
   0.6%
Household Income   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Cedis per month
Number Analyzed 160 participants
1144  (665)
[1]
Measure Description: Average currency exchange rate for recruitment period: 1 United States Dollar (USD) = 4.04 Cedis
[2]
Measure Analysis Population Description: Two participants did not wish to disclose this information.
BMI upon entering third trimester for current pregnancy   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 162 participants
27.7  (4.1)
[1]
Measure Description: This is the participants BMI in the period between 26 and 30 weeks' gestation for the current pregnancy.
Pre-pregnancy BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 162 participants
25.8  (3.9)
[1]
Measure Description: BMI at the beginning of the current pregnancy
Nightly sleep duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 162 participants
8.3  (1.5)
[1]
Measure Description: This is the participant's self-reported average nightly sleep duration in the past week.
In the last week, sleep onset position  
Measure Type: Count of Participants
Unit of measure:  Participants
Left Number Analyzed 162 participants
75
  46.3%
Supine Number Analyzed 162 participants
11
   6.8%
Right Number Analyzed 162 participants
76
  46.9%
Prone Number Analyzed 162 participants
0
   0.0%
In the last week, waking position  
Measure Type: Count of Participants
Unit of measure:  Participants
Left Number Analyzed 162 participants
67
  41.4%
Supine Number Analyzed 162 participants
25
  15.4%
Right Number Analyzed 162 participants
70
  43.2%
Prone Number Analyzed 162 participants
0
   0.0%
When not pregnant, sleep onset position  
Measure Type: Count of Participants
Unit of measure:  Participants
Left Number Analyzed 162 participants
1
   0.6%
Supine Number Analyzed 162 participants
87
  53.7%
Right Number Analyzed 162 participants
24
  14.8%
Prone Number Analyzed 162 participants
50
  30.9%
When not pregnant, waking position  
Measure Type: Count of Participants
Unit of measure:  Participants
Left Number Analyzed 162 participants
0
   0.0%
Supine Number Analyzed 162 participants
97
  59.9%
Right Number Analyzed 162 participants
31
  19.1%
Prone Number Analyzed 162 participants
34
  21.0%
Part of bed sleeps on  
Measure Type: Count of Participants
Unit of measure:  Participants
Left Number Analyzed 162 participants
50
  30.9%
Right Number Analyzed 162 participants
108
  66.7%
Center Number Analyzed 162 participants
1
   0.6%
Other Number Analyzed 162 participants
3
   1.9%
Pillow use  
Measure Type: Count of Participants
Unit of measure:  Participants
None Number Analyzed 162 participants
16
   9.9%
Under head Number Analyzed 162 participants
146
  90.1%
Between knees Number Analyzed 162 participants
1
   0.6%
Under tummy Number Analyzed 162 participants
0
   0.0%
Behind back Number Analyzed 162 participants
0
   0.0%
Pregnancy pillow Number Analyzed 162 participants
0
   0.0%
Under feet Number Analyzed 162 participants
37
  22.8%
Under legs Number Analyzed 162 participants
0
   0.0%
Sleeps with bed partner  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
119
  73.5%
Uses insecticide treated bed net  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
50
  30.9%
Snores ≥3 nights per week  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
12
   7.4%
Past medical complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
4
   2.5%
1.Primary Outcome
Title Birth Weight of Baby
Hide Description At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: grams
3033  (514)
2.Primary Outcome
Title Customized Birth Weight Centile
Hide Description

Individual customized birth weight centile calculated using the Gestation Network (Perinatal Institute; Birmingham, UK) Bulk Centile Calculator (BCC), which calculates customized birthweight centiles using the principles of the Gestation Related Optimal Weight (GROW) method.

The main non-pathological factors affecting birth weight are gestational age, maternal height, maternal weight at booking, parity, and ethnic group. The sex of fetus/neonate, when known, should also be adjusted for. These six variables need to be adjusted for to calculate the true growth potential, which can be represented as individually customized fetal growth curves and birth weight percentiles using the principles of the GROW. This method for calculating growth potential has been validated in a number of international studies.

Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: percentile
46.0  (30.5)
3.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Gestational age at delivery (weeks) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: Weeks
38.3  (2.5)
4.Secondary Outcome
Title Small for Gestational Age
Hide Description Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.
Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
25
  15.4%
5.Secondary Outcome
Title Low Birth Weight
Hide Description Low birth weight is defined has birth weight ≤ 2500 grams.
Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
21
  13.0%
6.Secondary Outcome
Title Sex of Newborn
Hide Description Sex of participant's newborn.
Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
Male
82
  50.6%
Female
80
  49.4%
7.Secondary Outcome
Title Preterm Delivery
Hide Description Preterm delivery is defined as gestational age at birth <37 weeks.
Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
42
  25.9%
8.Secondary Outcome
Title Mode of Delivery
Hide Description Mode of delivery (spontaneous vaginal, Cesarean section, instrumented) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Arm/Group Title Controls
Hide Arm/Group Description:

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
Spontaneous vaginal
122
  75.3%
Caesarean section
40
  24.7%
Instrumented
0
   0.0%
Time Frame From delivery of infant (spontaneous vaginal delivery, instrumented vaginal delivery, cesarean section delivery) through discharge of the participant from hospital, which was 24 hours for a spontaneous vaginal delivery and 48 hours for an instrumented vaginal delivery or cesarean section delivery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Controls
Hide Arm/Group Description

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.

No interventions will be administered.

All-Cause Mortality
Controls
Affected / at Risk (%)
Total   0/162 (0.00%) 
Hide Serious Adverse Events
Controls
Affected / at Risk (%)
Total   0/162 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Controls
Affected / at Risk (%)
Total   0/162 (0.00%) 
Reliance on participant's self reports for some baseline characteristics data (e.g., pre-pregnancy BMI, sleep positions).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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. Allan Kember, Director of Programs
Organization: Global Innovations for Reproductive Health & Life
Phone: +1-902-580-8385
EMail: allan.kember@mail.utoronto.ca
Publications:
Layout table for additonal information
Responsible Party: Allan Kember, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03062228    
Other Study ID Numbers: KBTH-IRB/00020/2016
First Submitted: February 19, 2017
First Posted: February 23, 2017
Results First Submitted: June 13, 2018
Results First Posted: March 31, 2020
Last Update Posted: March 31, 2020