Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
NCT ID: NCT02379728
Last Updated: 2020-04-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
200 participants
INTERVENTIONAL
2015-09-30
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
NCT06693817
Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition
NCT02622373
Evaluation of Postural Control in Premature Children
NCT04562909
Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients
NCT06157203
Validation of Sensors for Long-term Non-Invasive Fetal Monitoring
NCT06952777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
According to the World Health Organization (WHO), stillbirth (SB) is defined as fetal death at gestation ≥28 weeks or weight ≥1000g. In addition to the loss of life for the stillborn baby, parents whose baby is stillborn must cope with the psychological grief of losing their baby, which results in markedly increased mortality in bereaved parents when compared with non-bereaved parents.
Low birth-weight (LBW) is defined as a weight less than 2500g at birth. LBW is a significant contributor to SB, and infants with LBW are 20 times more likely to die in the first year than heavier babies. Although LBW babies constitute only about 15% of live births, they account for 60-80% of neonatal deaths. Neonatal deaths (death within the first year of life) account for 40% of all deaths under the age of five years. LBW also accounts for significant morbidity such as cognitive impairment, and chronic diseases later in life. LBW arises through short gestation (preterm birth) or in-utero growth restriction, or both.
Women in Ghana suffer from one of the highest perinatal mortality rates in the world. Every day in Ghana, 47 babies are stillborn and 232 babies are born with LBW - many of whom will die in infancy or suffer lifelong consequences. As such, Ghana urgently requires inexpensive interventions to reduce perinatal morbidity and mortality - assisting pregnant Ghanaian women to avoid sleeping on their back might be one such intervention.
Background - Maternal Position:
In obstetrics, it is well-known that when a pregnant woman assumes the supine position (laying on her back) during the day, maternal cardiovascular parameters and/or fetal oxygenation are altered, occasionally causing significant fetal heart rate changes, particularly during labor. However, until recently, there has been little evidence on the effect of supine position during sleep in pregnancy. Recently, three studies have suggested that maternal sleep position may be a risk factor for SB and LBW. This is significant given that the majority of third trimester pregnant women spend up to 25% of their sleep time supine. In the Auckland Stillbirth Study, the population attributable risk (PAR) for non-left sleep position to SB was found to be 37%, which is greater than the PARs of the three most important modifiable risk factors for SB (obesity, advanced maternal age, and smoking) combined. In an African population, investigators on this protocol found that supine sleep during pregnancy was an independent predictor of LBW (OR, 5.0; 95% confidence interval (CI), 1.2-20.2; P=0.025) and SB (OR, 8.0; 95% CI, 1.5-43.2; P=0.016), when controlling for covariates maternal age, gestational age, parity, and the presence of pre-eclampsia. Notably, LBW was found to mediate the relationship between supine sleep and SB. Currently, there is much interest and follow up research occurring worldwide, with a growing body of evidence regarding the detrimental effects of supine sleep position on pregnancy outcomes.
One proposed model is that the maternal supine position during sleep is a stressor that plays a causative role in LBW and SB via compression of the abdominal aorta and inferior vena cava ('aortocaval compression'), resulting in negative sequelae. The investigators hypothesize that by mitigating this stressor, they may protect the fetus from LBW or SB.
Background - Maternal Device:
Given the emerging data suggesting that supine sleep may play a role in LBW and SB and the high perinatal mortality rate in Ghana, a simple intervention may allow the investigators to improve fetal outcomes.
Some pregnant women sleep with many pillows supporting their body, including a pillow behind their back to avoid the supine position. Asking women to sleep on their left increases the percentage of left sided sleep to approximately 60% of the night; however, this may come at a cost of a slightly reduced sleep duration, perhaps due to women feeling they need to make a conscious effort to maintain a certain sleep position.
Hence, a simple, low-cost, and easily-implemented device has been developed for use by pregnant women to mitigate this risk factor. The investigators anticipate that using this device will remove the need for the woman to make a conscious effort to avoid the supine sleeping position. The device name is 'PrenaBelt'. The PrenaBelt is currently at the prototype stage of development, and as such, this proposal is a proof-of-concept/feasibility project.
The PrenaBelt is a belt-like, positional therapy device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back during sleep, it is expected to significantly decrease the amount of time she spends in this position via the mechanism of positional therapy. Positional therapy is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or mild to moderate obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back. These subtle pressure points activate her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back during sleep. The PrenaBelt is also designed for adjustability and comfort.
The investigators have designed an electronic Body Position Sensor (BPS) that can be securely integrated into a pocket on the PrenaBelt. The BPS will record body position of the user (left, right, prone, supine). The BPS is for research purposes only.
Study Design:
The feasibility (technical, operational, cultural), efficacy, acceptability, and compliance of the PrenaBelt intervention in the target population during the third trimester of pregnancy in an antenatal care clinic and home settings and the effect of PrenaBelt treatment on birth weight will be evaluated via a sham-controlled, double-blind, randomized controlled trial. Preliminary data will be collected for the design of a future, large-scale, parallel-group, randomized controlled trial to determine the efficacy of the PrenaBelt intervention in improving pregnancy outcomes in a resource-limited setting.
A small cohort of participants from the treatment and control groups will be randomly selected to use BPS's throughout the third trimester of pregnancy. Each BPS participant in the treatment group will be matched to a BPS participant in the control group using BMI (normal, overweight, obese) and age (within 5 years; 2.5 years each side) as matching variables and BPS data will be compared. These data will serve as preliminary objective evidence of PrenaBelt usage and effect on maternal sleeping position during the third trimester of pregnancy in the target population and setting.
Potential Harms:
This study is minimal risk. Participants in this study are at no greater risk of harms when completing the activities of this study than those risks they encounter in their everyday life.
The PrenaBelt, sham-PrenaBelt, and Body Position Sensor devices are non-invasive medical devices of Health Canada Class I designation. Pregnant women typically sleep with many pillows supporting their body, including a pillow behind their back to avoid the supine position. The PrenaBelt is a positional therapy device that may assist pregnant women to avoid supine sleep. Positional therapy devices have been shown to be safe and approved for use by humans by the US Food and Drug Administration. In addition, maternal body pillows, regular pillows, and pelvic belts (lumbar support) have been used by pregnant women during sleep without reports of serious adverse effects for the mother or neonate \[Victoria Pennick and Sarah D Liddle, "Interventions for preventing and treating pelvic and back pain in pregnancy (Review)," The Cochrane Collaboration, London, Review 2013\].
Participants in both the intervention and control groups may experience discomfort while learning to sleep with the PrenaBelt/sham-PrenaBelt, which theoretically may lead to delayed onset of sleep, arousals from sleep, and loss of sleep. Participants will be instructed how to, and told that they can, remove the PrenaBelt/sham-PrenaBelt and discontinue use at any time without penalty if they become too uncomfortable.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PrenaBelt
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.
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.
PrenaBelt with Body Position Sensor
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.
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.
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.
Control
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.
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.
Control with Body Position Sensor (BPS)
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Korle-Bu Teaching Hospital, Accra, Ghana
OTHER
Grand Challenges Canada
OTHER
Innovative Canadians for Change
OTHER
Global Innovations for Reproductive Health and Life
OTHER
Kaishin Chu Design
INDUSTRY
Allan Kember
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Allan Kember
Medical Student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heather M Scott, MD FRCSC
Role: STUDY_CHAIR
The IWK Health Centre
Jerry Coleman, MB ChB FWACS
Role: PRINCIPAL_INVESTIGATOR
Korle Bu Teaching Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Korle Bu Teaching Hospital
Accra, Greater Accra Region, Ghana
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FDA/CT/152
Identifier Type: OTHER
Identifier Source: secondary_id
GCC-S7-0629-01-10-ACC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.