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

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

Interventions

DEVICE

PrenaBelt

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.

DEVICE

Body Position Sensor

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.

DEVICE

sham-PrenaBelt

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.

Sponsors & Collaborators

• Korle-Bu Teaching Hospital, Accra, Ghana

  collaborator OTHER

• Grand Challenges Canada

  collaborator OTHER

• Innovative Canadians for Change

  collaborator OTHER

• Global Innovations for Reproductive Health and Life

  collaborator OTHER

• Kaishin Chu Design

  collaborator INDUSTRY

• Allan Kember

  lead OTHER

Principal Investigators

• Heather M Scott, MD FRCSC · The IWK Health Centre

• Jerry Coleman, MB ChB FWACS · Korle Bu Teaching Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• Ghana

Study Locations