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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

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
Infant, Small for Gestational Age Infant, Low Birth Weight Pregnancy Sleep Infant, Very Low Birth Weight Fetal Growth Retardation

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.

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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 : April 28, 2016
Actual Primary Completion Date : February 22, 2017
Actual Study Completion Date : March 1, 2017


Group/Cohort
Controls

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

No interventions will be administered.




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Sex of Newborn [ Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) ]
    Sex of participant's newborn.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062228


Locations
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Ghana
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
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Principal Investigator: Maxfield Okere, B.Sc. Korle Bu Teaching Hospital
  Study Documents (Full-Text)

Documents provided by Allan Kember, IWK Health Centre:
Study Protocol  [PDF] July 20, 2016
Statistical Analysis Plan  [PDF] July 20, 2016

Publications:

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Responsible Party: Allan Kember, Medical Student, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03062228    
Other Study ID Numbers: KBTH-IRB/00020/2016
First Posted: February 23, 2017    Key Record Dates
Results First Posted: March 31, 2020
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allan Kember, IWK Health Centre:
stillbirth
sleep
low birth weight
pregnancy
supine
small for gestational age
Additional relevant MeSH terms:
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Fetal Growth Retardation
Body Weight
Birth Weight
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes