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