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

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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

Tracking Information
First Submitted Date February 19, 2017
First Posted Date February 23, 2017
Results First Submitted Date June 13, 2018
Results First Posted Date March 31, 2020
Last Update Posted Date March 31, 2020
Actual Study Start Date April 28, 2016
Actual Primary Completion Date February 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2017)
  • Birth Weight of Baby [ Time Frame: 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.
  • Customized Birth Weight Centile [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 19, 2020)
  • Gestational Age at Delivery [ Time Frame: 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.
  • Small for Gestational Age [ Time Frame: 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.
  • Low Birth Weight [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Low birth weight is defined has birth weight ≤ 2500 grams.
  • Sex of Newborn [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Sex of participant's newborn.
  • Preterm Delivery [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Preterm delivery is defined as gestational age at birth <37 weeks.
  • Mode of Delivery [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: February 19, 2017)
  • Age [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Age of participant in years
  • Occupation [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Never employed, employed in the past, or currently employed. If employed in the past or currently employed, what occupation?
  • Gravidity [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Number of times participant has been pregnant (including this pregnancy).
  • Term [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Number of term births (after 37 weeks gestation) participant has had (including this pregnancy).
  • Premature [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Number of premature births (20-37 weeks gestation) participant has had.
  • Abortion [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Number of abortions participant has had.
  • Living [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Number of pregnancies participant delivered a live baby.
  • Usual weight [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Weight at beginning of current pregnancy.
  • Usual height [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Height at beginning of current pregnancy.
  • Usual bed time [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Time of day participant usually goes to bed for the night for the current pregnancy.
  • Usual wake time [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Time of day participant usually wakes up for the day for the current pregnancy.
  • Usual total sleep time [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Number of hours participant usually slept each night for the current pregnancy.
  • Going-to-sleep position in last week [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Position (right side, left side, prone, supine, other) participant usually goes to sleep in for the past week (before labor and delivery).
  • Waking up position in last week [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Position (right side, left side, prone, supine, other) participant usually wakes up in for the past week (before labor and delivery).
  • Going-to-sleep position while not pregnant [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Position (right side, left side, prone, supine, other) participant usually goes to sleep in while not pregnant.
  • Waking-up position while not pregnant [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Position (right side, left side, prone, supine, other) participant usually wakes up in while not pregnant.
  • Usual position on bed [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Part of bed (left, right, center, other) that the participant usually sleeps on.
  • Mosquito net use [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Whether or not (yes or no) the participant uses a mosquito net over her bed while sleeping in it.
  • Use of pillows [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Participant's use of pillows during sleep (None, under head, between knees, under tummy, behind back, pregnancy pillow, other).
  • Bed occupants [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Whether or not (yes or no) anyone else sleeps in the bed with the participant.
  • Self-reported snoring [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Whether or not (yes or no) the participant snores 3 or more nights per week.
  • Medical problems in the past [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Whether or not (yes or no) the participant has had medical problems in the past, and if "yes", what medical problems they have had (e.g., intra-uterine growth restriction, diabetes [gestational or not], hypertension [pre-eclampsia, gestational, chronic], other).
  • Family income [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Ghanaian Cedi per month (optional question)
  • Education level [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Primary, junior secondary, secondary, tertiary education
  • Mode of Delivery [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Mode of delivery (unassisted, episiotomy, amniotomy, induced, fetal monitoring, forceps delivery, vacuum extraction, Cesarean section) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
  • Gestational Age at Delivery [ Time Frame: 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.
  • Third-trimester weight [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    The participant's health record will be reviewed to extract her weight at 26-30 weeks. This information is recorded in her health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
  • Third-trimester height [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    The participant's health record will be reviewed to extract her height at 26-30 weeks. This information is recorded in her health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
  • Sex [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    The sex of the participant's baby (male/female).
  • Ethnicity [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Participants ethnicity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
Official Title Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The participants (subjects) will be healthy, Ghanaian women who have recently delivered a live birth at KBTH. The inclusion/exclusion criteria criteria will be similar to the Ghana PrenaBelt Trial with one difference (* below) and one additional inclusion criterion (** below).
Condition
  • Infant, Small for Gestational Age
  • Infant, Low Birth Weight
  • Pregnancy
  • Sleep
  • Infant, Very Low Birth Weight
  • Fetal Growth Retardation
Intervention Not Provided
Study Groups/Cohorts Controls

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

No interventions will be administered.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 19, 2017)
162
Original Estimated Enrollment Same as current
Actual Study Completion Date March 1, 2017
Actual Primary Completion Date February 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ghana
Removed Location Countries  
 
Administrative Information
NCT Number NCT03062228
Other Study ID Numbers KBTH-IRB/00020/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Allan Kember, IWK Health Centre
Study Sponsor IWK Health Centre
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
Investigators
Principal Investigator: Maxfield Okere, B.Sc. Korle Bu Teaching Hospital
PRS Account IWK Health Centre
Verification Date March 2020