Clinical trial NCT03062228: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Small for Gestational Age
Infant, Low Birth Weight
Pregnancy
Sleep
Infant, Very Low Birth Weight
Fetal Growth Retardation
Keywords: stillbirth
sleep
low birth weight
pregnancy
supine
small for gestational age
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Korle Bu Teaching Hospital
name: University of Michigan
name: Innovative Canadians for Change
name: Dalhousie University
name: Global Innovations for Reproductive Health & Life
name: University of Ghana Medical School
First posted: 2017-02-23
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

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

Primary outcomes:
measure: Birth Weight of Baby
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
measure: Customized Birth Weight Centile
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Secondary outcomes:
measure: Gestational Age at Delivery
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
measure: Small for Gestational Age
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
measure: Low Birth Weight
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
measure: Sex of Newborn
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
measure: Preterm Delivery
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
measure: Mode of Delivery
timeFrame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Other outcomes:
Locations:
city: Korle Bu
country: Ghana
facility: Korle Bu Teaching Hospital
state: Accra
Study officials:
affiliation: Korle Bu Teaching Hospital
name: Maxfield Okere, B.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Owusu JT, Anderson FJ, Coleman J, Oppong S, Seffah JD, Aikins A, O'Brien LM. Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Int J Gynaecol Obstet. 2013 Jun;121(3):261-5. doi: 10.1016/j.ijgo.2013.01.013. Epub 2013 Mar 15.
citation: Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403.
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