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

NACompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
SleepPregnancyStillbirthInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, Very Low Birth WeightFetal Growth RetardationFetal 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.

Trial Locations (1)

Unknown

Korle Bu Teaching Hospital, Accra

All Listed Sponsors
collaborator

Korle-Bu Teaching Hospital, Accra, Ghana

OTHER

collaborator

Grand Challenges Canada

OTHER

collaborator

Innovative Canadians for Change

OTHER

collaborator

Global Innovations for Reproductive Health and Life

OTHER

collaborator

Kaishin Chu Design

INDUSTRY

lead

Allan Kember

OTHER

NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth | Biotech Hunter | Biotech Hunter