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

Study Overview
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Brief Summary
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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.

Detailed Description
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Introduction: 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.

Official Title
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A Maternal Device to Reduce the Risk of Stillbirth and Low Birth-Weight

Conditions
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Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation, Fetal Hypoxia

Intervention / Treatment
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* Device: PrenaBelt
* Device: Body Position Sensor
* Device: sham-PrenaBelt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old 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: BMI ≥ 35 at booking (first antenatal appointment for current pregnancy) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrenaBelt<br>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. | Device: PrenaBelt<br>* 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.<br>|
| Experimental: PrenaBelt with Body Position Sensor<br>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. | Device: PrenaBelt<br>* 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.<br>Device: Body Position Sensor<br>* 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.<br>|
| Sham Comparator: Control<br>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. | Device: sham-PrenaBelt<br>* 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.<br>|
| Sham Comparator: Control with Body Position Sensor (BPS)<br>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. | Device: Body Position Sensor<br>* 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.<br>Device: sham-PrenaBelt<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birthweight of Baby | Birthweight was measured using a Detecto newborn scale (Webb City, USA) and documented in the participant's hospital folder immediately after delivery by a midwife who was not a part of the study team and was not aware of the treatment allocation. Birthweight was subsequently abstracted by the blinded outcomes assessor. Analysis was by original assigned groups and on a complete-case basis (drop-outs excluded). The newborns included in the final analysis were born from November 31, 2015 through May 13, 2016. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Birthweight Centile | Birthweight centile was calculated using the Gestation-Related Optimal Weight (GROW) software,(1,2) which accounts for the main non-pathological factors affecting birthweight (gestational age, maternal height, maternal weight at booking, parity, ethnicity, and sex of the neonate) and, as such, enables delineation between constitutional and pathological smallness and more accurate detection of pregnancies at increased risk for adverse outcomes.(3,4) This was an additional trial outcome specified after trial commencement. Gardosi J, Francis A. Customized Weight Centile Calculator. Gestation Network; 2016. Available from: www.gestation.net Gardosi J, et al. Customised antenatal growth charts. Lancet. Elsevier; 1992 Feb;339(8788):283-7. Gardosi J. Horm Res. 2006;65(SUPPL. 3):15-8. Odibo A O, et al. J Matern Neonatal Med. 2011 Mar 10; 24(3):411-7. | At delivery of baby (on average, 38 - 40 weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Age at Delivery | Gestational age at delivery (weeks) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Mode of Delivery | Mode of delivery (unassisted, episiotomy, amniotomy, induced, fetal monitoring, forceps delivery, vacuum extraction, Cesarean section) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Sex of Newborn (Male/Female) | Sex of the newborn will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Stillbirth | If a stillbirth occurs, it will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Low Birthweight | Low birthweight is defined as a birthweight ≤ 2500 grams at birth. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Small for Gestational Age | Small for gestational age is defined as a Gestation-Related Optimal Weight (GROW) birthweight centile ≤ 10%. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Preterm Delivery | Preterm delivery was defined as a gestational age (in weeks) at birth of less than 37 weeks, 0 days. | At delivery of baby (on average, 38 - 40 weeks gestation) | 
| Received ≥ 1 Obstetrical Diagnosis During Labor/Delivery | Any relevant diagnosis/diagnoses made during labor/delivery (e.g., gestational diabetes, gestational hypertension, meconium aspiration) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital. | At delivery of baby (on average, 38 - 40 weeks gestation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positional therapy, tennis ball technique, sleep pregnancy, supine position, supine, sleep position, low birth weight, stillbirth, intrauterine growth restriction