The Product: PrenaBelt®

Meticulously-engineered, clinically-tested, and internationally-published. Antepartum, intrapartum, and postpartum. Night and day. We've got your back like no one else.

 

The PrenaBelt® is the first and only clinically-tested and internationally-published positional therapy device for sleep in late pregnancy.[1-4] The PrenaBelt® takes the worry out of sleep in late pregnancy by minimizing or eliminating one of the few remaining modifiable risk factors for late stillbirth: sleeping flat on the back in late pregnancy. See our Sleeping Position in Pregnancy page for more information.

The PrenaBelt® has followed the iterative design process with at least three major revisions between our first proof-of-concept and the fabulous product that we have today, and we are currently developing a size-inclusive PrenaBelt® for body mass index (BMI) up to 60kg/m². During each of these revisions, we consulted with customers and each component of the PrenaBelt® was scrutinized, prototyped, and tested, and has undergone multiple design improvements.

As an example of the iterative design process, engineers on our Development Team regularly conduct finite element analyses (FEA) on the PrenaBelt® positional therapy attachments from one design to the next revision to model and compare component stability and deflections under simulated loading conditions as pictured below.

 

Further, we are proud to have pioneered the first ever skin-mattress interface pressure analysis (SMIPA, pictured below) in pregnancy to understand how the PrenaBelt® positional therapy attachments and comfort accessories alter the contact area and resultant pressures and forces generated at the interface between the pregnant body and the sleeping surface. Engineers from our Development Team also use this data to understand how the PrenaBelt® positional therapy attachments and comfort accessories affect pregnancy and sleep biomechanics and how these can be optimized for user comfort.

 

The PrenaBelt® is manufactured in facilities that have been assessed and certified by external certification bodies as meeting the requirements of:

• ISO 9001:2015 - Quality management systems — Requirements
• ISO 13485:2016 - Quality management systems — Requirements for regulatory purposes

The PrenaBelt® is a Class I medical device by Rule 7(1) (Medical Devices Regulations, SOR/98-282, Schedule 1, Section 6 - Classification Rules for Medical Devices, Part 1). The indications of use for the PrenaBelt® are as follows:

1. Primary Indication: Provide positional therapy to the pregnant abdomen and pelvis. 
2. Secondary Indication: Provide musculoskeletal support to the hips, pregnant abdomen and pelvis, and lower back. 
3. Tertiary Indication: Provide thermal therapy for the relief of discomfort.

IMPORTANT NOTE: The PrenaBelt® does NOT claim to prevent stillbirth, intrauterine fetal death, low birth weight, or growth restriction and is NOT indicated for the prevention, diagnosis, or treatment such diagnoses.

The PrenaBelt® exerts a compression level of a medical compressive grade 1 category.

If worn at a compression level exceeding its intended use, the PrenaBelt® can create an average maximum compression of 0.85 psi (44.0 mmHg). This pressure is only applied over the anterior superior iliac spines. Under this worst-case condition, the compression applied to the pelvic region posteriorly and anteriorly remains similar to those levels when the PrenaBelt® is worn as intended.

Click/tap here to learn more about the research behind the PrenaBelt®.

References:

1. Coleman J, et al. 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.
2. Coleman J, et al. 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.
3. Kember AJ, et al. Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised pilot trial. BMJ Open, 2018.
4. Warland J, et al. Modifying maternal sleep position in late pregnancy through positional therapy: A feasibility study. J Clin Sleep Med, 2018.

Disclaimer: The information provided on this page is for informational purposes only and is not professional medical advice, diagnosis, treatment, or care, nor is it intended to be a substitute therefore.