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

Sponsor
IWK Health Centre (Other)
Overall Status
Completed
CT.gov ID
NCT03062228
Collaborator
Korle Bu Teaching Hospital (Other), University of Michigan (Other), Innovative Canadians for Change (Other), Dalhousie University (Other), Global Innovations for Reproductive Health & Life (Other), University of Ghana Medical School (Other)
162
Enrollment
1
Location
10.1
Actual Duration (Months)
16.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. This study will seek to establish the typical birth weight of babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep during pregnancy nor have received a device to prevent back sleep.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Recently, three studies have suggested that maternal back sleep may be a risk factor for stillbirth (SB) and low birth weight (LBW). This is significant given that the majority of third-trimester pregnant women spend up to 25% of their sleep time on their back. The Ghana PrenaBelt Trial (GPT), completed by our team at the Korle Bu Teaching Hospital (KBTH) from September 2015 - May 2016, was the first interventional trial investigating this possible relationship between maternal back sleep and LBW. However, a limitation of the GPT was that due to its sham-control design, all participants in the trial (treatment group and sham-control group) were educated during the consent process about back-sleep in late pregnancy as a possible risk factor for SB and LBW. At interim analysis of the GPT (February 2016), no difference in birth weight was found between the two groups. Also around this time, the study team had anecdotal reports from sham-group participants who indicated that they trained themselves to sleep exclusively on their left side. Further, there is evidence in the literature that when instructed to sleep on their left, third-trimester pregnant women can increase the percentage of left-sided sleep to approximately 60% of the night on average and maintain this across multiple nights.

    Given this, it was questioned if the back-sleep education during the consent process could be having an effect on the sleep behaviour of the GPT participants independently of their treatment allocation; therefore, the KBTH-GIRHL Healthy Birth Weight Study was designed in March 2016 to investigate this question further. The aim of this study is to establish a reference birth weight of babies born to a cohort of women comparable to the cohort in the GPT but who have not received back-sleep education, did not participate in the GPT, and whose babies were born in a similar time period and weighed on the same newborn scales - in essence, a control group for the GPT.

    This cross-sectional study will be accomplished via recruiting a control group from a pool of women having recently delivered at KBTH, reviewing their hospital records, and having them complete a short survey about their demographics, obstetric history, and sleep behaviors.

    The results of this study, together with the results of the GPT, will enable us to determine whether or not education about back-sleep in pregnancy affects pregnancy outcomes, specifically birth weight.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    162 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section
    Actual Study Start Date :
    Apr 28, 2016
    Actual Primary Completion Date :
    Feb 22, 2017
    Actual Study Completion Date :
    Mar 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Controls

    Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.

    Outcome Measures

    Primary Outcome Measures

    1. Birth Weight of Baby [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      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.

    2. Customized Birth Weight Centile [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      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.

    Secondary Outcome Measures

    1. Gestational Age at Delivery [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      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.

    2. Small for Gestational Age [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.

    3. Low Birth Weight [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      Low birth weight is defined has birth weight ≤ 2500 grams.

    4. Sex of Newborn [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      Sex of participant's newborn.

    5. Preterm Delivery [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      Preterm delivery is defined as gestational age at birth <37 weeks.

    6. Mode of Delivery [Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Low-risk singleton pregnancy

    • *Delivered a live birth >28 weeks gestation at KBTH within the past 48 hours.

    • Residing in the Greater Accra Metropolitan Area or area served by the KBTH.

    • Fluent in either English, Twi, or Ga

    • **Has not received education/ information about back sleep position in pregnancy as a potential risk factor for stillbirth and low birth weight.

    Exclusion Criteria:

    • BMI ≥ 35 at booking (first antenatal appointment for current pregnancy)

    • Pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth])

    • Sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder])

    • Multiple pregnancy

    • Known fetal abnormality

    • Maternal age >35

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korle Bu Teaching Hospital Korle Bu Accra Ghana

    Sponsors and Collaborators

    • IWK Health Centre
    • Korle Bu Teaching Hospital
    • University of Michigan
    • Innovative Canadians for Change
    • Dalhousie University
    • Global Innovations for Reproductive Health & Life
    • University of Ghana Medical School

    Investigators

    • Principal Investigator: Maxfield Okere, B.Sc., Korle Bu Teaching Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Allan Kember, Medical Student, IWK Health Centre
    ClinicalTrials.gov Identifier:
    NCT03062228
    Other Study ID Numbers:
    • KBTH-IRB/00020/2016
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Mar 31, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Allan Kember, Medical Student, IWK Health Centre
    stillbirth
    sleep
    low birth weight
    pregnancy
    supine
    small for gestational age
    Additional relevant MeSH terms:
    Fetal Growth Retardation
    Body Weight
    Birth Weight

    Study Results

    Participant Flow

    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 Detail 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
    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

    Baseline Characteristics

    Arm/Group Title Controls
    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 Participants 162
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    28.7
    (4.4)
    Sex: Female, Male (Count of Participants)
    Female
    162
    100%
    Male
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Ghanaian
    162
    100%
    Region of Enrollment (Count of Participants)
    Ghana
    162
    100%
    Gravidity (Count of Participants)
    Gravida 1
    33
    20.4%
    Gravida ≥2
    129
    79.6%
    Parity (Count of Participants)
    Para 1
    44
    27.2%
    Para ≥2
    118
    72.8%
    Education level (Count of Participants)
    Tertiary
    21
    13%
    Vocational
    1
    0.6%
    Senior High
    52
    32.1%
    Junior High
    57
    35.2%
    Primary
    30
    18.5%
    Undisclosed
    1
    0.6%
    Household Income (Cedis per month) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Cedis per month]
    1144
    (665)
    BMI upon entering third trimester for current pregnancy (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    27.7
    (4.1)
    Pre-pregnancy BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    25.8
    (3.9)
    Nightly sleep duration (hours) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [hours]
    8.3
    (1.5)
    In the last week, sleep onset position (Count of Participants)
    Left
    75
    46.3%
    Supine
    11
    6.8%
    Right
    76
    46.9%
    Prone
    0
    0%
    In the last week, waking position (Count of Participants)
    Left
    67
    41.4%
    Supine
    25
    15.4%
    Right
    70
    43.2%
    Prone
    0
    0%
    When not pregnant, sleep onset position (Count of Participants)
    Left
    1
    0.6%
    Supine
    87
    53.7%
    Right
    24
    14.8%
    Prone
    50
    30.9%
    When not pregnant, waking position (Count of Participants)
    Left
    0
    0%
    Supine
    97
    59.9%
    Right
    31
    19.1%
    Prone
    34
    21%
    Part of bed sleeps on (Count of Participants)
    Left
    50
    30.9%
    Right
    108
    66.7%
    Center
    1
    0.6%
    Other
    3
    1.9%
    Pillow use (Count of Participants)
    None
    16
    9.9%
    Under head
    146
    90.1%
    Between knees
    1
    0.6%
    Under tummy
    0
    0%
    Behind back
    0
    0%
    Pregnancy pillow
    0
    0%
    Under feet
    37
    22.8%
    Under legs
    0
    0%
    Sleeps with bed partner (Count of Participants)
    Count of Participants [Participants]
    119
    73.5%
    Uses insecticide treated bed net (Count of Participants)
    Count of Participants [Participants]
    50
    30.9%
    Snores ≥3 nights per week (Count of Participants)
    Count of Participants [Participants]
    12
    7.4%
    Past medical complications (Count of Participants)
    Count of Participants [Participants]
    4
    2.5%

    Outcome Measures

    1. Primary Outcome
    Title Birth Weight of Baby
    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)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Mean (Standard Deviation) [grams]
    3033
    (514)
    2. Primary Outcome
    Title Customized Birth Weight Centile
    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)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Mean (Standard Deviation) [percentile]
    46.0
    (30.5)
    3. Secondary Outcome
    Title Gestational Age at Delivery
    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)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Mean (Standard Deviation) [Weeks]
    38.3
    (2.5)
    4. Secondary Outcome
    Title Small for Gestational Age
    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)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Count of Participants [Participants]
    25
    15.4%
    5. Secondary Outcome
    Title Low Birth Weight
    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)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Count of Participants [Participants]
    21
    13%
    6. Secondary Outcome
    Title Sex of Newborn
    Description Sex of participant's newborn.
    Time Frame Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Male
    82
    50.6%
    Female
    80
    49.4%
    7. Secondary Outcome
    Title Preterm Delivery
    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)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Count of Participants [Participants]
    42
    25.9%
    8. Secondary Outcome
    Title Mode of Delivery
    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)

    Outcome Measure Data

    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
    Arm/Group Description Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
    Measure Participants 162
    Spontaneous vaginal
    122
    75.3%
    Caesarean section
    40
    24.7%
    Instrumented
    0
    0%

    Adverse Events

    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
    Arm/Group Title Controls
    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 (%) # Events
    Total 0/162 (0%)
    Serious Adverse Events
    Controls
    Affected / at Risk (%) # Events
    Total 0/162 (0%)
    Other (Not Including Serious) Adverse Events
    Controls
    Affected / at Risk (%) # Events
    Total 0/162 (0%)

    Limitations/Caveats

    Reliance on participant's self reports for some baseline characteristics data (e.g., pre-pregnancy BMI, sleep positions).

    More Information

    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

    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
    Responsible Party:
    Allan Kember, Medical Student, IWK Health Centre
    ClinicalTrials.gov Identifier:
    NCT03062228
    Other Study ID Numbers:
    • KBTH-IRB/00020/2016
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Mar 31, 2020
    Last Verified:
    Mar 1, 2020