Pregnancy Clinical Trial
Official title:
Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section
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.
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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