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

Pregnancy Clinical Trial

— KBTH-HBWS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062228
• Other study ID #: KBTH-IRB/00020/2016
• Status: Completed
• Start date: April 28, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2020
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 1, 2017
• Est. primary completion date: February 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Fetal Growth Retardation
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Very Low Birth Weight
• Pregnancy
• Sleep

Locations

Country	Name	City	State
Ghana	Korle Bu Teaching Hospital	Korle Bu	Accra

Sponsors (7)

Lead Sponsor	Collaborator
IWK Health Centre	Dalhousie University, Global Innovations for Reproductive Health & Life, Innovative Canadians for Change, Korle Bu Teaching Hospital, University of Ghana Medical School, University of Michigan

Country where clinical trial is conducted

Ghana, 

References & Publications (10)

Gardosi J, Chang A, Kalyan B, Sahota D, Symonds EM. Customised antenatal growth charts. Lancet. 1992 Feb 1;339(8788):283-7. — View Citation

Gardosi J, Mongelli M, Wilcox M, Chang A. An adjustable fetal weight standard. Ultrasound Obstet Gynecol. 1995 Sep;6(3):168-74. — View Citation

Gordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction, and late-pregnancy stillbirth: the Sydney stillbirth study. Obstet Gynecol. 2015 Feb;125(2):347-55. doi: 10.1097/AOG.0000000000000627. — View Citation

O'Brien LM, Warland J. Typical sleep positions in pregnant women. Early Hum Dev. 2014 Jun;90(6):315-7. doi: 10.1016/j.earlhumdev.2014.03.001. Epub 2014 Mar 21. — View 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. — View Citation

Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171. — View 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. — View Citation

Stone PR, Burgess W, McIntyre JP, Gunn AJ, Lear CA, Bennet L, Mitchell EA, Thompson JM; Maternal Sleep In Pregnancy Research Group, The University of Auckland. Effect of maternal position on fetal behavioural state and heart rate variability in healthy late gestation pregnancy. J Physiol. 2017 Feb 15;595(4):1213-1221. doi: 10.1113/JP273201. Epub 2016 Dec 11. — View Citation

Warland J, Dorrian J. Accuracy of self-reported sleep position in late pregnancy. PLoS One. 2014 Dec 23;9(12):e115760. doi: 10.1371/journal.pone.0115760. eCollection 2014. — View Citation

Warland J, Mitchell EA. A triple risk model for unexplained late stillbirth. BMC Pregnancy Childbirth. 2014 Apr 14;14:142. doi: 10.1186/1471-2393-14-142. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Sex of Newborn	Sex of participant's newborn.	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Secondary	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)
Secondary	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)