KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section

Study Overview
=================
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.

Official Title
-----------------
Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section

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

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth Weight of Baby | 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 
| Customized Birth Weight Centile | 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Age at Delivery | 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 
| Small for Gestational Age | Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 
| Low Birth Weight | Low birth weight is defined has birth weight ≤ 2500 grams. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 
| Sex of Newborn | Sex of participant's newborn. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 
| Preterm Delivery | Preterm delivery is defined as gestational age at birth <37 weeks. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 
| Mode of Delivery | 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stillbirth, sleep, low birth weight, pregnancy, supine, small for gestational age