Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth

NCT02379728 | Completed Results

• 2 other identifiers: GCC-S7-0629-01-10-ACCFDA/CT/152
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences. Sleeping on the back during pregnancy has recently emerged in scientific literature as a potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate this link was conducted in Ghana by investigators on this protocol. When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of the major veins that delivers blood back to her heart and may completely obstruct it. This may result in less blood being returned to her heart and less blood being pumped to her developing fetus. Such changes may negatively impact the growth of her fetus and, along with some other risk factors, may contribute to the death of her baby. The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount of time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple, safe, effective, and well-established modality called positional therapy. The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their home setting via an antenatal care clinic and local health-care staff. Data from this study will be used in effect size calculations for the design of a large-scale, epidemiological study targeted at reducing LBW and SB in Ghana and globally.

Conditions

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

Keywords

positional therapy; tennis ball technique; sleep pregnancy; supine position; supine; sleep position; low birth weight; stillbirth; intrauterine growth restriction

Outcome Measures

Primary Outcomes (2)

• Birthweight of Baby

  Birthweight was measured using a Detecto newborn scale (Webb City, USA) and documented in the participant's hospital folder immediately after delivery by a midwife who was not a part of the study team and was not aware of the treatment allocation. Birthweight was subsequently abstracted by the blinded outcomes assessor. Analysis was by original assigned groups and on a complete-case basis (drop-outs excluded). The newborns included in the final analysis were born from November 31, 2015 through May 13, 2016.

  At delivery of baby (on average, 38 - 40 weeks gestation)

• Birthweight Centile

  Birthweight centile was calculated using the Gestation-Related Optimal Weight (GROW) software,(1,2) which accounts for the main non-pathological factors affecting birthweight (gestational age, maternal height, maternal weight at booking, parity, ethnicity, and sex of the neonate) and, as such, enables delineation between constitutional and pathological smallness and more accurate detection of pregnancies at increased risk for adverse outcomes.(3,4) This was an additional trial outcome specified after trial commencement. 1. Gardosi J, Francis A. Customized Weight Centile Calculator. Gestation Network; 2016. Available from: www.gestation.net 2. Gardosi J, et al. Customised antenatal growth charts. Lancet. Elsevier; 1992 Feb;339(8788):283-7. 3. Gardosi J. Horm Res. 2006;65(SUPPL. 3):15-8. 4. Odibo A O, et al. J Matern Neonatal Med. 2011 Mar 10; 24(3):411-7.

  At delivery of baby (on average, 38 - 40 weeks gestation)

Secondary Outcomes (8)

• Gestational Age at Delivery

  At delivery of baby (on average, 38 - 40 weeks gestation)

• Mode of Delivery

  At delivery of baby (on average, 38 - 40 weeks gestation)

• Sex of Newborn (Male/Female)

  At delivery of baby (on average, 38 - 40 weeks gestation)

• Stillbirth

  At delivery of baby (on average, 38 - 40 weeks gestation)

• Low Birthweight

  At delivery of baby (on average, 38 - 40 weeks gestation)

Other Outcomes (24)

• Medical Staff Questionnaire - Session Time Requirement

  From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

• Medical Staff Questionnaire - Session Delivery

  From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

• Medical Staff Questionnaire - Session Difficulties

  From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Study Arms (4)

PrenaBelt

EXPERIMENTAL

Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: PrenaBelt

PrenaBelt with Body Position Sensor

EXPERIMENTAL

Participants will be instructed to use the PrenaBelt (with integrated body position sensor (BPS)) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: PrenaBelt; Device: Body Position Sensor

Control

SHAM COMPARATOR

Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: sham-PrenaBelt

Control with Body Position Sensor (BPS)

SHAM COMPARATOR

Participants will be instructed to use the sham-PrenaBelt (with integrated BPS) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: Body Position Sensor; Device: sham-PrenaBelt

Interventions

PrenaBelt DEVICE

The PrenaBelt (PB) is a belt-like, positional therapy (PT) device designed for pregnant women. While the PB does not prevent the user from lying on her back during sleep, it is expected to significantly decrease the amount of time a user spends supine via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition. The PB is worn at the level of the waist or thorax. By design, the PB affects subtle pressure points on the user's back while supine, activating her body's natural mechanism to reposition itself to relieve discomfort, thereby reducing the amount of time spent supine.

PrenaBelt; PrenaBelt with Body Position Sensor

Body Position Sensor DEVICE

The Body Position Sensor (BPS) is for research purposes only. The BPS can be securely integrated into a pocket on the PrenaBelt (PrenaBelt with BPS Arm) or sham-PrenaBelt (Control with BPS Arm). The BPS is a small, electronic data acquisition device. The BPS uses a three axes accelerometer to detect orientation of the PrenaBelt, and thus the user (right, left, prone, supine), in three-dimensional space. The accelerometer data is collected continually with time stamping and stored on the BPS hard drive and can be accessed via connecting it to a computer. The BPS is not expected to affect the body position of the user.

Control with Body Position Sensor (BPS); PrenaBelt with Body Position Sensor

sham-PrenaBelt DEVICE

The PrenaBelt can be easily converted into a sham-PrenaBelt for research purposes by removing the hard balls from its pockets or exchanging these hard balls for soft balls so it cannot provide pressure points, i.e., positional therapy function. The sham-PrenaBelt looks, fits, and feels like the PrenaBelt but cannot provide positional therapy.

Control; Control with Body Position Sensor (BPS)

Eligibility Criteria

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

You may qualify if:

• ≥18 years old
• low-risk singleton pregnancy
• entering the last trimester of pregnancy (in range 26-30 weeks of gestation)
• residing in the Greater Accra Metropolitan Area or area served by the Korle Bu Teaching Hospital
• fluent in either English, Twi, or Ga.

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

• Allan Kember: lead
• Korle-Bu Teaching Hospital, Accra, Ghana: collaborator
• Grand Challenges Canada: collaborator
• Innovative Canadians for Change: collaborator
• Global Innovations for Reproductive Health and Life: collaborator
• Kaishin Chu Design: collaborator

Study Sites (1)

Korle Bu Teaching Hospital

Accra, Greater Accra Region, Ghana

Location

Related Publications (8)

• 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

• Coleman J, Grewal S, Warland J, Hobson S, Liu K, Kember A. Maternal positional therapy for fetal growth and customised birth weight centile benefit in a Bayesian reanalysis of a double-blind, sham-controlled, randomised clinical trial. BMJ Open. 2024 Apr 28;14(4):e078315. doi: 10.1136/bmjopen-2023-078315.

  PMID: 38684260 DERIVED

• Coleman J, Okere M, Seffah J, Kember A, O'Brien LM, Borazjani A, Butler M, Wells J, MacRitchie S, Isaac A, Chu K, Scott H. The Ghana PrenaBelt trial: a double-blind, sham-controlled, randomised clinical trial to evaluate the effect of maternal positional therapy during third-trimester sleep on birth weight. BMJ Open. 2019 May 1;9(4):e022981. doi: 10.1136/bmjopen-2018-022981.

  PMID: 31048420 DERIVED

Related Links

• Allan Kember's (Project Lead, Project Principal Investigator) blog - Project Updates
• Grand Challenges Canada - News Release
• Global Innovations for Reproductive Health and Life - Project Page

MeSH Terms

Conditions

Stillbirth; Fetal Growth Retardation; Fetal Hypoxia; Deception

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Did not include a non-intervention control group. Determination of adherence to device use was largely subjective, relying mostly on participants' self-reports. Low adherence rates. May be under-powered to detect a clinically meaningful difference.

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

• Heather M Scott, MD FRCSC

  The IWK Health Centre

  STUDY CHAIR

• Jerry Coleman, MB ChB FWACS

  Korle Bu Teaching Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 5, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 2, 2020
• Results First Posted: April 2, 2020

Record last verified: 2020-03

Locations

GH (1)