Korle Bu Teaching Hospital
Korle Bu, Accra, Ghana
NCT Number: NCT03062228
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.
Looking for future studies?
Notify Me18 year–35 year
Female
Observational
Korle Bu, Accra, Ghana
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Sex of participant's newborn.
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.
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.
IWK Health Centre
Other
Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section
Acronym: KBTH-HBWS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02377817
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Halifax, Nova Scotia, Canada
View Trial DetailsNCT02379728
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Accra, Greater Accra Region, Ghana
View Trial DetailsNCT02189265
Death, Death, Sudden
Amsterdam, North Holland, Netherlands
View Trial DetailsNCT02812914
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Exposure to Environmental Pollution, Non-occupational
San Lorenzo, Guatemala
View Trial Details