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

NCT03062228 | Completed Results

• 1 other identifier: KBTH-IRB/00020/2016
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stillbirth; sleep; low birth weight; pregnancy; supine; small for gestational age

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Gestational Age at Delivery

  Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)

• Small for Gestational Age

  Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)

• Low Birth Weight

  Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)

• Sex of Newborn

  Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)

• Preterm Delivery

  Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)

Study Arms (1)

Controls

Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead
• Korle Bu Teaching Hospital: collaborator
• University of Michigan: collaborator
• Innovative Canadians for Change: collaborator
• Dalhousie University: collaborator
• Global Innovations for Reproductive Health & Life: collaborator
• University of Ghana Medical School: collaborator

Study Sites (1)

Korle Bu Teaching Hospital

Korle Bu, Accra, Ghana

Location

Related Publications (10)

• 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.

  PMID: 23507553 BACKGROUND

• 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.

  PMID: 21673002 BACKGROUND

• 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):347-355. doi: 10.1097/AOG.0000000000000627.

  PMID: 25568999 BACKGROUND

• 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.

  PMID: 24885461 BACKGROUND

• 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.

  PMID: 24731396 BACKGROUND

• 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.

  PMID: 24661447 BACKGROUND

• 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.

  PMID: 27871127 BACKGROUND

• 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.

  PMID: 25535960 BACKGROUND

• Gardosi J, Chang A, Kalyan B, Sahota D, Symonds EM. Customised antenatal growth charts. Lancet. 1992 Feb 1;339(8788):283-7. doi: 10.1016/0140-6736(92)91342-6.

  PMID: 1346292 BACKGROUND

• Gardosi J, Mongelli M, Wilcox M, Chang A. An adjustable fetal weight standard. Ultrasound Obstet Gynecol. 1995 Sep;6(3):168-74. doi: 10.1046/j.1469-0705.1995.06030168.x.

  PMID: 8521065 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation; Stillbirth; Deception

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Death; Death; Social Behavior; Behavior

Limitations and Caveats

Reliance on participant's self reports for some baseline characteristics data (e.g., pre-pregnancy BMI, sleep positions).

Results Point of Contact

• Title: Dr. Allan Kember, Director of Programs
• Organization: Global Innovations for Reproductive Health & Life

allan.kember@mail.utoronto.ca

+1-902-580-8385

Study Officials

• Maxfield Okere, B.Sc.

  Korle Bu Teaching Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 23, 2017
• Study Start: April 28, 2016
• Primary Completion: February 22, 2017
• Study Completion: March 1, 2017
• Last Updated: March 31, 2020
• Results First Posted: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)