Fetal Growth Retardation, Fetal Hypoxia, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Pregnancy, Sleep, Stillbirth
Conditions
Keywords
positional therapy, tennis ball technique, sleep pregnancy, supine position, supine, sleep position, low birth weight, stillbirth, intrauterine growth restriction
Brief 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.
Interventions
DEVICEPrenaBelt
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.
DEVICEBody 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.
DEVICEsham-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.
Sponsors
Korle-Bu Teaching Hospital, Accra, Ghana
Grand Challenges Canada
Innovative Canadians for Change
Global Innovations for Reproductive Health and Life
Kaishin Chu Design
Allan Kember
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birthweight of Baby | At delivery of baby (on average, 38 - 40 weeks gestation) | 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. |
| Birthweight Centile | At delivery of baby (on average, 38 - 40 weeks gestation) | 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. 1. Gardosi J, Francis A. Customized Weight Centile Calculator. Gestation Network; 2016. Available from: www.gestation.net 2. Gardosi J, et al. Customised antenatal growth charts. Lancet. Elsevier; 1992 Feb;339(8788):283-7. 3. Gardosi J. Horm Res. 2006;65(SUPPL. 3):15-8. 4. Odibo A O, et al. J Matern Neonatal Med. 2011 Mar 10; 24(3):411-7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Received ≥ 1 Obstetrical Diagnosis During Labor/Delivery | At delivery of baby (on average, 38 - 40 weeks gestation) | 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. |
| Gestational Age at Delivery | At delivery of baby (on average, 38 - 40 weeks gestation) | 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. |
| Mode of Delivery | At delivery of baby (on average, 38 - 40 weeks gestation) | 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. |
| Sex of Newborn (Male/Female) | At delivery of baby (on average, 38 - 40 weeks gestation) | 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. |
| Stillbirth | At delivery of baby (on average, 38 - 40 weeks gestation) | 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. |
| Low Birthweight | At delivery of baby (on average, 38 - 40 weeks gestation) | Low birthweight is defined as a birthweight ≤ 2500 grams at birth. |
| Small for Gestational Age | At delivery of baby (on average, 38 - 40 weeks gestation) | Small for gestational age is defined as a Gestation-Related Optimal Weight (GROW) birthweight centile ≤ 10%. |
| Preterm Delivery | At delivery of baby (on average, 38 - 40 weeks gestation) | Preterm delivery was defined as a gestational age (in weeks) at birth of less than 37 weeks, 0 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PrenaBelt User Feedback Questionnaire - Learning | At delivery of baby (on average, 38 - 40 weeks gestation) | When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to learn how to use the PrenaBelt? Check box categories: Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not put the PrenaBelt on correctly. |
| PrenaBelt User Feedback Questionnaire - General Adherence Pattern | At delivery of baby (on average, 38 - 40 weeks gestation) | Did the participant use the PrenaBelt regularly (almost every night)? Check box categories: Regularly throughout her entire third trimester. More regularly at the beginning and less at the end. Less regularly at the beginning and more at the end. Not regularly at any time. |
| PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | At delivery of baby (on average, 38 - 40 weeks gestation) | When the participant was using the PrenaBelt, did she use it: Check box categories: Every night of the week. 6 nights per week. 7 nights per week. 5 nights per week. 4 nights per week. 3 nights per week. 2 nights per week. 1 nights per week. Did not use it at all. |
| PrenaBelt User Feedback Questionnaire - Deterrents to Use | At delivery of baby (on average, 38 - 40 weeks gestation) | Did anyone tell the participant to stop using the PrenaBelt or that she should not be using the PrenaBelt (yes/no; if yes, explain) |
| PrenaBelt User Feedback Questionnaire - Other Uses | At delivery of baby (on average, 38 - 40 weeks gestation) | Did the participant or anyone else use the PrenaBelt for anything else during daily activities besides sleep (yes/no; if yes, explain). |
| PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | At delivery of baby (on average, 38 - 40 weeks gestation) | How does the participant think the PrenaBelt affected her sleep position. Check box categories: Participant didn't notice any difference in her sleep position Participant changed position more often. Participant spent more time sleeping on her left side. Participant woke up more often during the night when she was on her back, would roll back onto her left side, and fall asleep. Over time, participant learned to not sleep on her back and woke up less at night. In the mornings, participant always woke up on her left side. Other, please specify: |
| PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | At delivery of baby (on average, 38 - 40 weeks gestation) | In general, did the participant notice anything else that was different about her sleep when using the PrenaBelt. Check box categories: Participant's sleep quality improved. Participant's sleep quality worsened. Participant's sleep duration became longer. Participant's sleep duration became shorter. During the day, participant felt more alert. During the day, participant felt more drowsy. Participant stopped snoring. Participant started snoring. Participant woke up less often throughout the night. Other, please specify: |
| PrenaBelt User Feedback Questionnaire - Satisfaction | At delivery of baby (on average, 38 - 40 weeks gestation) | On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note: 1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied |
| PrenaBelt User Feedback Questionnaire - Comfort | At delivery of baby (on average, 38 - 40 weeks gestation) | On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note: 1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable |
| PrenaBelt User Feedback Questionnaire - Intention for Future Use | At delivery of baby (on average, 38 - 40 weeks gestation) | On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her. Note: 1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again |
| Sleep Diary - PrenaBelt Adherence | Throughout third trimester (on average, from 28 through 40 weeks gestation) | Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated. |
| Sleep Diary - Number of Nights in Trial | Throughout third trimester (on average, from 28 through 40 weeks gestation) | Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated. |
| Sleep Diary - Number of Nights Used Device | Throughout third trimester (on average, from 28 through 40 weeks gestation) | Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated. |
| Body Position Sensor Participant Adherence | Throughout third trimester (on average, from 28 through 40 weeks gestation) | Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby. |
| Body Position Sensor Participant Time Used Per Night | Throughout third trimester (on average, from 28 through 40 weeks gestation) | Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby. |
| Body Position Sensor Participant Sleep Time by Position | Throughout third trimester (on average, from 28 through 40 weeks gestation) | Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby. |
| Medical Staff Questionnaire - Session Time Requirement | From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months) | How long it took (in minutes), on average, to complete the Introduction and Instruction for PrenaBelt session. |
| Medical Staff Questionnaire - Session Delivery | From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months) | How the medical staff person delivered the Introduction and Instruction for PrenaBelt session (e.g., one-on-one, in a group setting, or both) and the staff person's preference for delivery. |
| Medical Staff Questionnaire - Session Difficulties | From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months) | Did the medical staff person or the participants encounter any difficulties during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe) |
| Medical Staff Questionnaire - Session Cultural Issues | From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months) | Were any cultural issues encountered during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe). |
| Medical Staff Questionnaire - Professional Training Level | From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months) | The professional training level (e.g., nursing, midwifery) of the medical staff person. |
| Medical Staff Questionnaire - Professional Experience | From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months) | The professional experience (years working as a professional) of the medical staff person. |
| Medical Staff Questionnaire - Professional Difficulty Rating | From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months) | In comparison to the medical staff person's training and experience, the difficulty rating of delivering the sessions on a scale from 1 to 10: 1 = Easy - medical staff person could have completed the sessions without training and experience. 5 = Medium difficulty - medical staff person needed to use some professional training and experience. 10 = Very difficult - professional training and experience did not help medical staff person at all |
| PrenaBelt User Feedback Questionnaire - Understanding | At delivery of baby (on average, 38 - 40 weeks gestation) | When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to understand the PrenaBelt? Check box categories: Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not understand it. |
Countries
Ghana
Participant flow
Recruitment details
Participants were recruited by maternity personnel when presenting for antenatal care at the Korle Bu Teaching Hospital. Between September 2015 and March 2016, 276 women were assessed for eligibility. Seventy-six (28%) did not meet the eligibility criteria. When the target enrollment (N=200) was reached, recruitment was stopped.
Participants by arm
| Arm | Count |
|---|---|
| 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.
A small subset of this group (n=16) will have a body position sensor (BPS) 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. | 82 |
| 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.
A small subset of this group (n=16) will have a body position sensor (BPS) 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. | 80 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 3 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 5 | 3 |
Baseline characteristics
| Characteristic | PrenaBelt | Control | Total |
|---|---|---|---|
| Age, Continuous | 29 years | 29 years | 29 years |
| Current BMI | 28.9 kg/m^2 STANDARD_DEVIATION 4.2 | 28.9 kg/m^2 STANDARD_DEVIATION 4.3 | 28.9 kg/m^2 STANDARD_DEVIATION 4.3 |
| Education Junior High or less | 16 Participants | 5 Participants | 21 Participants |
| Education Senior High | 15 Participants | 26 Participants | 41 Participants |
| Education Tertiary | 50 Participants | 48 Participants | 98 Participants |
| Education Vocational | 1 Participants | 1 Participants | 2 Participants |
| Gestational age (weeks) | 28 weeks | 28 weeks | 28 weeks |
| Gravidity Gravida 1 | 20 Participants | 31 Participants | 51 Participants |
| Gravidity Gravida ≥2 | 62 Participants | 49 Participants | 111 Participants |
| Household Income | 1200 Cedis per month | 1500 Cedis per month | 1350 Cedis per month |
| In the last week, sleep onset position Left | 41 Participants | 46 Participants | 87 Participants |
| In the last week, sleep onset position Prone | 2 Participants | 0 Participants | 2 Participants |
| In the last week, sleep onset position Right | 33 Participants | 29 Participants | 62 Participants |
| In the last week, sleep onset position Supine | 12 Participants | 8 Participants | 20 Participants |
| In the last week, waking position Left | 30 Participants | 32 Participants | 62 Participants |
| In the last week, waking position Prone | 4 Participants | 2 Participants | 6 Participants |
| In the last week, waking position Right | 26 Participants | 31 Participants | 57 Participants |
| In the last week, waking position Supine | 22 Participants | 18 Participants | 40 Participants |
| Nightly sleep duration | 7.8 Hours STANDARD_DEVIATION 1.3 | 8.2 Hours STANDARD_DEVIATION 1.3 | 8.0 Hours STANDARD_DEVIATION 1.3 |
| Parity Para 0 | 29 Participants | 38 Participants | 67 Participants |
| Parity Para ≥1 | 53 Participants | 42 Participants | 95 Participants |
| Part of bed sleeps on Center | 11 Participants | 12 Participants | 23 Participants |
| Part of bed sleeps on Left | 42 Participants | 31 Participants | 73 Participants |
| Part of bed sleeps on Right | 30 Participants | 35 Participants | 65 Participants |
| Past medical complications | 4 Participants | 2 Participants | 6 Participants |
| Pillow use Behind back | 4 Participants | 4 Participants | 8 Participants |
| Pillow use Between knees | 7 Participants | 5 Participants | 12 Participants |
| Pillow use None | 3 Participants | 6 Participants | 9 Participants |
| Pillow use Other (under feet or legs) | 2 Participants | 6 Participants | 8 Participants |
| Pillow use Pregnancy pillow | 1 Participants | 0 Participants | 1 Participants |
| Pillow use Under head | 74 Participants | 71 Participants | 145 Participants |
| Pillow use Under tummy | 4 Participants | 0 Participants | 4 Participants |
| Pre-pregnancy BMI | 26.1 kg/m^2 STANDARD_DEVIATION 4.2 | 26.2 kg/m^2 STANDARD_DEVIATION 4.1 | 26.2 kg/m^2 STANDARD_DEVIATION 4.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Ghana | 82 participants | 80 participants | 162 participants |
| Sex: Female, Male Female | 82 Participants | 80 Participants | 162 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sleeps with bed partner | 65 Participants | 61 Participants | 126 Participants |
| Snores ≥3 nights per week | 9 Participants | 7 Participants | 16 Participants |
| Uses insecticide treated bed net | 19 Participants | 17 Participants | 36 Participants |
| When not pregnant, sleep onset positions Left | 6 Participants | 7 Participants | 13 Participants |
| When not pregnant, sleep onset positions Prone | 42 Participants | 39 Participants | 81 Participants |
| When not pregnant, sleep onset positions Right | 10 Participants | 9 Participants | 19 Participants |
| When not pregnant, sleep onset positions Supine | 25 Participants | 26 Participants | 51 Participants |
| When not pregnant, waking positions Left | 12 Participants | 10 Participants | 22 Participants |
| When not pregnant, waking positions Prone | 32 Participants | 27 Participants | 59 Participants |
| When not pregnant, waking positions Right | 15 Participants | 14 Participants | 29 Participants |
| When not pregnant, waking positions Supine | 25 Participants | 29 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 35 / 100 | 34 / 100 |
| serious Total, serious adverse events | 6 / 100 | 13 / 100 |
Outcome results
Primary
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. 1. Gardosi J, Francis A. Customized Weight Centile Calculator. Gestation Network; 2016. Available from: www.gestation.net 2. Gardosi J, et al. Customised antenatal growth charts. Lancet. Elsevier; 1992 Feb;339(8788):283-7. 3. Gardosi J. Horm Res. 2006;65(SUPPL. 3):15-8. 4. Odibo A O, et al. J Matern Neonatal Med. 2011 Mar 10; 24(3):411-7.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrenaBelt | Birthweight Centile | 43 percent |
| Control | Birthweight Centile | 32 percent |
Primary
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.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PrenaBelt | Birthweight of Baby | 3186 grams | Standard Deviation 484 |
| Control | Birthweight of Baby | 3079 grams | Standard Deviation 493 |
Secondary
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.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrenaBelt | Gestational Age at Delivery | 39.1 Weeks |
| Control | Gestational Age at Delivery | 39.0 Weeks |
Secondary
Low Birthweight
Low birthweight is defined as a birthweight ≤ 2500 grams at birth.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrenaBelt | Low Birthweight | 7 Participants |
| Control | Low Birthweight | 6 Participants |
Secondary
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.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | Mode of Delivery | Spontaneous vaginal | 50 Participants |
| PrenaBelt | Mode of Delivery | Caesarean section | 32 Participants |
| PrenaBelt | Mode of Delivery | Vacuum extraction | 0 Participants |
| Control | Mode of Delivery | Spontaneous vaginal | 38 Participants |
| Control | Mode of Delivery | Caesarean section | 40 Participants |
| Control | Mode of Delivery | Vacuum extraction | 2 Participants |
Secondary
Preterm Delivery
Preterm delivery was defined as a gestational age (in weeks) at birth of less than 37 weeks, 0 days.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrenaBelt | Preterm Delivery | 5 Participants |
| Control | Preterm Delivery | 8 Participants |
Secondary
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.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrenaBelt | Received ≥ 1 Obstetrical Diagnosis During Labor/Delivery | 31 Participants |
| Control | Received ≥ 1 Obstetrical Diagnosis During Labor/Delivery | 41 Participants |
Secondary
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.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | Sex of Newborn (Male/Female) | Male | 50 Participants |
| PrenaBelt | Sex of Newborn (Male/Female) | Female | 32 Participants |
| Control | Sex of Newborn (Male/Female) | Male | 39 Participants |
| Control | Sex of Newborn (Male/Female) | Female | 41 Participants |
Secondary
Small for Gestational Age
Small for gestational age is defined as a Gestation-Related Optimal Weight (GROW) birthweight centile ≤ 10%.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrenaBelt | Small for Gestational Age | 12 Participants |
| Control | Small for Gestational Age | 18 Participants |
Secondary
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.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrenaBelt | Stillbirth | 0 Participants |
| Control | Stillbirth | 1 Participants |
Other Pre-specified
Body Position Sensor Participant Adherence
Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby.
Time frame: Throughout third trimester (on average, from 28 through 40 weeks gestation)
Population: Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrenaBelt | Body Position Sensor Participant Adherence | 19 % of days |
| Control | Body Position Sensor Participant Adherence | 33 % of days |
Other Pre-specified
Body Position Sensor Participant Sleep Time by Position
Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby.
Time frame: Throughout third trimester (on average, from 28 through 40 weeks gestation)
Population: Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PrenaBelt | Body Position Sensor Participant Sleep Time by Position | Percentage sleep time left | 27 % of total sleep time |
| PrenaBelt | Body Position Sensor Participant Sleep Time by Position | Percentage sleep time right (%) | 35 % of total sleep time |
| PrenaBelt | Body Position Sensor Participant Sleep Time by Position | Percentage sleep time supine (%) | 45 % of total sleep time |
| Control | Body Position Sensor Participant Sleep Time by Position | Percentage sleep time left | 31 % of total sleep time |
| Control | Body Position Sensor Participant Sleep Time by Position | Percentage sleep time right (%) | 34 % of total sleep time |
| Control | Body Position Sensor Participant Sleep Time by Position | Percentage sleep time supine (%) | 37 % of total sleep time |
Other Pre-specified
Body Position Sensor Participant Time Used Per Night
Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby.
Time frame: Throughout third trimester (on average, from 28 through 40 weeks gestation)
Population: Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrenaBelt | Body Position Sensor Participant Time Used Per Night | 5.3 hours |
| Control | Body Position Sensor Participant Time Used Per Night | 5.4 hours |
Other Pre-specified
Medical Staff Questionnaire - Professional Difficulty Rating
In comparison to the medical staff person's training and experience, the difficulty rating of delivering the sessions on a scale from 1 to 10: 1 = Easy - medical staff person could have completed the sessions without training and experience. 5 = Medium difficulty - medical staff person needed to use some professional training and experience. 10 = Very difficult - professional training and experience did not help medical staff person at all
Time frame: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)
Population: Four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PrenaBelt | Medical Staff Questionnaire - Professional Difficulty Rating | 4 units on a scale |
Other Pre-specified
Medical Staff Questionnaire - Professional Experience
The professional experience (years working as a professional) of the medical staff person.
Time frame: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)
Population: Four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PrenaBelt | Medical Staff Questionnaire - Professional Experience | 8.33 years |
Other Pre-specified
Medical Staff Questionnaire - Professional Training Level
The professional training level (e.g., nursing, midwifery) of the medical staff person.
Time frame: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)
Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | Medical Staff Questionnaire - Professional Training Level | Nurse with diploma in public health | 1 Participants |
| PrenaBelt | Medical Staff Questionnaire - Professional Training Level | Nurse with diploma in midwifery | 3 Participants |
Other Pre-specified
Medical Staff Questionnaire - Session Cultural Issues
Were any cultural issues encountered during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe).
Time frame: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)
Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | Medical Staff Questionnaire - Session Cultural Issues | Yes | 0 Participants |
| PrenaBelt | Medical Staff Questionnaire - Session Cultural Issues | No | 4 Participants |
Other Pre-specified
Medical Staff Questionnaire - Session Delivery
How the medical staff person delivered the Introduction and Instruction for PrenaBelt session (e.g., one-on-one, in a group setting, or both) and the staff person's preference for delivery.
Time frame: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)
Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | Medical Staff Questionnaire - Session Delivery | One-on-one | 1 Participants |
| PrenaBelt | Medical Staff Questionnaire - Session Delivery | Group | 0 Participants |
| PrenaBelt | Medical Staff Questionnaire - Session Delivery | Both | 3 Participants |
Other Pre-specified
Medical Staff Questionnaire - Session Difficulties
Did the medical staff person or the participants encounter any difficulties during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe)
Time frame: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)
Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | Medical Staff Questionnaire - Session Difficulties | Yes | 1 Participants |
| PrenaBelt | Medical Staff Questionnaire - Session Difficulties | No | 3 Participants |
Other Pre-specified
Medical Staff Questionnaire - Session Time Requirement
How long it took (in minutes), on average, to complete the Introduction and Instruction for PrenaBelt session.
Time frame: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)
Population: Three, of four, maternity personnel conducting the device introduction sessions answered this question on the maternity personnel questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PrenaBelt | Medical Staff Questionnaire - Session Time Requirement | 10 minutes |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Comfort
On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note: 1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Comfort | 8 units on a scale |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Deterrents to Use
Did anyone tell the participant to stop using the PrenaBelt or that she should not be using the PrenaBelt (yes/no; if yes, explain)
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Deterrents to Use | Yes | 3 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Deterrents to Use | No | 52 Participants |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - General Adherence Pattern
Did the participant use the PrenaBelt regularly (almost every night)? Check box categories: Regularly throughout her entire third trimester. More regularly at the beginning and less at the end. Less regularly at the beginning and more at the end. Not regularly at any time.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - General Adherence Pattern | Regularly throughout her entire third trimester | 11 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - General Adherence Pattern | More regularly at the beginning, less at the end | 32 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - General Adherence Pattern | Less regularly at the beginning, more at the end | 3 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - General Adherence Pattern | Not regularly at any time | 5 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - General Adherence Pattern | No response | 4 Participants |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Intention for Future Use
On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her. Note: 1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Intention for Future Use | 8 units on a scale |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Learning
When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to learn how to use the PrenaBelt? Check box categories: Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not put the PrenaBelt on correctly.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Learning | No response | 3 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Learning | Easy | 51 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Learning | Medium | 1 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Learning | Difficult | 0 Participants |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week
When the participant was using the PrenaBelt, did she use it: Check box categories: Every night of the week. 6 nights per week. 7 nights per week. 5 nights per week. 4 nights per week. 3 nights per week. 2 nights per week. 1 nights per week. Did not use it at all.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | 1 nights per week. | 1 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | Did not use at all. | 0 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | Every night of the week. | 10 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | 6 nights per week. | 1 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | 5 nights per week. | 25 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | 4 nights per week. | 5 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | 3 nights per week. | 7 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | 2 nights per week. | 2 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Nights of Use Per Week | No response. | 4 Participants |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Other Uses
Did the participant or anyone else use the PrenaBelt for anything else during daily activities besides sleep (yes/no; if yes, explain).
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Other Uses | Yes | 0 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Other Uses | No | 55 Participants |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep
In general, did the participant notice anything else that was different about her sleep when using the PrenaBelt. Check box categories: Participant's sleep quality improved. Participant's sleep quality worsened. Participant's sleep duration became longer. Participant's sleep duration became shorter. During the day, participant felt more alert. During the day, participant felt more drowsy. Participant stopped snoring. Participant started snoring. Participant woke up less often throughout the night. Other, please specify:
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Stopped snoring | 2 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Started snoring | 0 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Woke up less often throughout the night | 11 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Other | 4 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Sleep quality improved | 32 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Sleep quality worsened | 2 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Sleep duration became longer | 6 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | Sleep duration became shorter | 21 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | During the day, participant felt more alert | 8 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep | During the day, participant felt more drowsy | 1 Participants |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position
How does the participant think the PrenaBelt affected her sleep position. Check box categories: Participant didn't notice any difference in her sleep position Participant changed position more often. Participant spent more time sleeping on her left side. Participant woke up more often during the night when she was on her back, would roll back onto her left side, and fall asleep. Over time, participant learned to not sleep on her back and woke up less at night. In the mornings, participant always woke up on her left side. Other, please specify:
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | Didn't notice a difference | 2 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | Changed position more often | 15 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | Spent more time sleeping on left | 26 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | Woke up on back, turned to left, fell asleep | 21 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | Learned not to sleep on back, woke up less often | 22 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | In morning, always woke up on her left | 17 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position | Other | 0 Participants |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Satisfaction
On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note: 1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Satisfaction | 8 units on a scale |
Other Pre-specified
PrenaBelt User Feedback Questionnaire - Understanding
When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to understand the PrenaBelt? Check box categories: Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not understand it.
Time frame: At delivery of baby (on average, 38 - 40 weeks gestation)
Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Understanding | Easy | 51 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Understanding | Difficult | 0 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Understanding | Medium | 1 Participants |
| PrenaBelt | PrenaBelt User Feedback Questionnaire - Understanding | No response | 3 Participants |
Other Pre-specified
Sleep Diary - Number of Nights in Trial
Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated.
Time frame: Throughout third trimester (on average, from 28 through 40 weeks gestation)
Population: 143 participants (68 treatments, 75 shams) completed and returned the sleep diary.Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PrenaBelt | Sleep Diary - Number of Nights in Trial | 80 Number of nights in trial | Standard Deviation 14 |
| Control | Sleep Diary - Number of Nights in Trial | 76 Number of nights in trial | Standard Deviation 16 |
Other Pre-specified
Sleep Diary - Number of Nights Used Device
Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated.
Time frame: Throughout third trimester (on average, from 28 through 40 weeks gestation)
Population: 143 participants (68 treatments, 75 shams) completed and returned the sleep diary.Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PrenaBelt | Sleep Diary - Number of Nights Used Device | 42 Number of nights used device | Standard Deviation 21 |
| Control | Sleep Diary - Number of Nights Used Device | 43 Number of nights used device | Standard Deviation 22 |
Other Pre-specified
Sleep Diary - PrenaBelt Adherence
Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated.
Time frame: Throughout third trimester (on average, from 28 through 40 weeks gestation)
Population: 143 participants (68 treatments, 75 shams) completed and returned the sleep diary.Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PrenaBelt | Sleep Diary - PrenaBelt Adherence | 52 % (#nights used/#nights in trial) | Standard Deviation 25 |
| Control | Sleep Diary - PrenaBelt Adherence | 56 % (#nights used/#nights in trial) | Standard Deviation 26 |