Project Lead(s): Allan Kember
In 2009, the World Health Organization reported the global rate of stillbirths (SB) to be 2.6 million per year, of which 98% occur in low- and middle-income countries (LMICs), with the highest concentrations in Sub-Saharan Africa. In addition, each year there are over 20 million infants born with low birth weight (LBW), of which 96% occur in LMICs, with the highest concentrations in Asia and Africa.
Research studies indicate that sleeping on one’s back in late pregnancy (28–40 weeks’ gestation) is significantly associated with delivering a SB and/or LBW baby.
The team invented a simple, wearable, belt-like device – called the ‘PrenaBelt’ – to be worn by a
pregnant woman when sleeping, to mitigate the risk of SB and LBW. The purpose of the PrenaBelt is to modify the sleep position by reducing the amount of time a pregnant woman spends sleeping on her back. The belt has rounded balls in it and applies light pressure points when the woman lays on her back, causing her body to favour lying on her side
The project included two randomized controlled trials.
In Canada, the team investigated the efficacy of the PrenaBelt in reducing time the woman spent sleeping on her back during the third trimester. In Ghana, the team investigated the effects of using the PrenaBelt on birth weight.
In Canada, the Halifax PrenaBelt Trial was a two-night, randomized, cross-over, sham-controlled, triple-blind sleep study involving 20 healthy pregnant women. The sham-PrenaBelt is a device that looks and feels like the PrenaBelt but cannot cause pressure points.
In Ghana, the Ghana PrenaBelt Trial was a sham-controlled, double-blind, randomized controlled trial in 200 healthy pregnant women. A total of 94 participants in the treatment group and 87 participants in the sham group completed the trial.
Based on an interim analysis of the Canadian trial with 14 subjects, participants were found to spend less time on their back at night with the PrenaBelt when compared with the sham-PrenaBelt, and this difference was statistically significant.
The PrenaBelt safety results in the trial in Ghana demonstrated that it is safe for use. However, for the primary endpoint (birth weight) and secondary outcomes (small-for-gestational age, low birth weight, gestational age at delivery, gender, mode of delivery, preterm, stillbirth), there was no difference between the study and the control groups.
The project team feels there may have been confounding factors in the study design that might have had an effect on sleep behavior, independent of the treatment assignment.
A similar study conducted by the team in Australia also yielded positive findings for both mother and fetus.
The scientific findings and technological innovations will be integrated into a social enterprise model of business that enables scalability and drives sustainability in both developed and developing countries.