Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
Condition: Sleep; Pregnancy; Stillbirth; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Very Low Birth Weight; Fetal Growth Retardation; Fetal Hypoxia
MeSH terms: Stillbirth; Fetal Growth Retardation; Fetal Hypoxia; Body Weight; Hypoxia; Birth Weight
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): PrenaBelt; Body Position Sensor; sham-PrenaBelt
Intervention type(s): Device; Device; Device
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: positional therapy; tennis ball technique; sleep pregnancy; supine position; supine; sleep position; low birth weight; stillbirth; intrauterine growth restriction