KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
Condition: Infant, Small for Gestational Age; Infant, Low Birth Weight; Pregnancy; Sleep; Infant, Very Low Birth Weight; Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation; Body Weight; Birth Weight
Study type: Observational

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.
    

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).
      
Keywords: stillbirth; sleep; low birth weight; pregnancy; supine; small for gestational age