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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379728
Recruitment Status : Completed
First Posted : March 5, 2015
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Collaborators:
Korle-Bu Teaching Hospital, Accra, Ghana
Grand Challenges Canada
Innovative Canadians for Change
Global Innovations for Reproductive Health and Life
Kaishin Chu Design
Information provided by (Responsible Party):
Allan Kember, IWK Health Centre

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.


Condition or disease Intervention/treatment Phase
Sleep Pregnancy Stillbirth Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Very Low Birth Weight Fetal Growth Retardation Fetal Hypoxia Device: PrenaBelt Device: Body Position Sensor Device: sham-PrenaBelt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Maternal Device to Reduce the Risk of Stillbirth and Low Birth-Weight
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PrenaBelt

Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.

Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: PrenaBelt

The PrenaBelt (PB) is a belt-like, positional therapy (PT) device designed for pregnant women. While the PB does not prevent the user from lying on her back during sleep, it is expected to significantly decrease the amount of time a user spends supine via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition.

The PB is worn at the level of the waist or thorax. By design, the PB affects subtle pressure points on the user's back while supine, activating her body's natural mechanism to reposition itself to relieve discomfort, thereby reducing the amount of time spent supine.


Experimental: PrenaBelt with Body Position Sensor

Participants will be instructed to use the PrenaBelt (with integrated body position sensor (BPS)) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep.

Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: PrenaBelt

The PrenaBelt (PB) is a belt-like, positional therapy (PT) device designed for pregnant women. While the PB does not prevent the user from lying on her back during sleep, it is expected to significantly decrease the amount of time a user spends supine via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition.

The PB is worn at the level of the waist or thorax. By design, the PB affects subtle pressure points on the user's back while supine, activating her body's natural mechanism to reposition itself to relieve discomfort, thereby reducing the amount of time spent supine.


Device: Body Position Sensor
The Body Position Sensor (BPS) is for research purposes only. The BPS can be securely integrated into a pocket on the PrenaBelt (PrenaBelt with BPS Arm) or sham-PrenaBelt (Control with BPS Arm). The BPS is a small, electronic data acquisition device. The BPS uses a three axes accelerometer to detect orientation of the PrenaBelt, and thus the user (right, left, prone, supine), in three-dimensional space. The accelerometer data is collected continually with time stamping and stored on the BPS hard drive and can be accessed via connecting it to a computer. The BPS is not expected to affect the body position of the user.

Sham Comparator: Control

Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.

Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: sham-PrenaBelt
The PrenaBelt can be easily converted into a sham-PrenaBelt for research purposes by removing the hard balls from its pockets or exchanging these hard balls for soft balls so it cannot provide pressure points, i.e., positional therapy function. The sham-PrenaBelt looks, fits, and feels like the PrenaBelt but cannot provide positional therapy.

Sham Comparator: Control with Body Position Sensor (BPS)

Participants will be instructed to use the sham-PrenaBelt (with integrated BPS) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep.

Participants will be followed by study personnel through the remainder of pregnancy and delivery.

Device: Body Position Sensor
The Body Position Sensor (BPS) is for research purposes only. The BPS can be securely integrated into a pocket on the PrenaBelt (PrenaBelt with BPS Arm) or sham-PrenaBelt (Control with BPS Arm). The BPS is a small, electronic data acquisition device. The BPS uses a three axes accelerometer to detect orientation of the PrenaBelt, and thus the user (right, left, prone, supine), in three-dimensional space. The accelerometer data is collected continually with time stamping and stored on the BPS hard drive and can be accessed via connecting it to a computer. The BPS is not expected to affect the body position of the user.

Device: sham-PrenaBelt
The PrenaBelt can be easily converted into a sham-PrenaBelt for research purposes by removing the hard balls from its pockets or exchanging these hard balls for soft balls so it cannot provide pressure points, i.e., positional therapy function. The sham-PrenaBelt looks, fits, and feels like the PrenaBelt but cannot provide positional therapy.




Primary Outcome Measures :
  1. Birthweight of Baby [ Time Frame: 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.


  2. Birthweight Centile [ Time Frame: 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 Outcome Measures :
  1. Gestational Age at Delivery [ Time Frame: 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.

  2. Mode of Delivery [ Time Frame: 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.

  3. Sex of Newborn (Male/Female) [ Time Frame: 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.

  4. Stillbirth [ Time Frame: 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.

  5. Low Birthweight [ Time Frame: At delivery of baby (on average, 38 - 40 weeks gestation) ]
    Low birthweight is defined as a birthweight ≤ 2500 grams at birth.

  6. Small for Gestational Age [ Time Frame: 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%.

  7. Preterm Delivery [ Time Frame: 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.

  8. Received ≥ 1 Obstetrical Diagnosis During Labor/Delivery [ Time Frame: 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.


Other Outcome Measures:
  1. Medical Staff Questionnaire - Session Time Requirement [ Time Frame: 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.

  2. Medical Staff Questionnaire - Session Delivery [ Time Frame: 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.

  3. Medical Staff Questionnaire - Session Difficulties [ Time Frame: 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)

  4. Medical Staff Questionnaire - Session Cultural Issues [ Time Frame: 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).

  5. Medical Staff Questionnaire - Professional Training Level [ Time Frame: 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.

  6. Medical Staff Questionnaire - Professional Experience [ Time Frame: 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.

  7. Medical Staff Questionnaire - Professional Difficulty Rating [ Time Frame: 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


  8. PrenaBelt User Feedback Questionnaire - Understanding [ Time Frame: 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.


  9. PrenaBelt User Feedback Questionnaire - Learning [ Time Frame: 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.


  10. PrenaBelt User Feedback Questionnaire - General Adherence Pattern [ Time Frame: 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.


  11. PrenaBelt User Feedback Questionnaire - Nights of Use Per Week [ Time Frame: 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.


  12. PrenaBelt User Feedback Questionnaire - Deterrents to Use [ Time Frame: 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)

  13. PrenaBelt User Feedback Questionnaire - Other Uses [ Time Frame: 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).

  14. PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position [ Time Frame: 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:


  15. PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep [ Time Frame: 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:


  16. PrenaBelt User Feedback Questionnaire - Satisfaction [ Time Frame: 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


  17. PrenaBelt User Feedback Questionnaire - Comfort [ Time Frame: 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


  18. PrenaBelt User Feedback Questionnaire - Intention for Future Use [ Time Frame: 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


  19. Sleep Diary - PrenaBelt Adherence [ Time Frame: 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.

  20. Sleep Diary - Number of Nights in Trial [ Time Frame: 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.

  21. Sleep Diary - Number of Nights Used Device [ Time Frame: 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.

  22. Body Position Sensor Participant Adherence [ Time Frame: 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.

  23. Body Position Sensor Participant Time Used Per Night [ Time Frame: 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.

  24. Body Position Sensor Participant Sleep Time by Position [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379728


Locations
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Ghana
Korle Bu Teaching Hospital
Accra, Greater Accra, Ghana
Sponsors and Collaborators
Allan Kember
Korle-Bu Teaching Hospital, Accra, Ghana
Grand Challenges Canada
Innovative Canadians for Change
Global Innovations for Reproductive Health and Life
Kaishin Chu Design
Investigators
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Study Chair: Heather M Scott, MD FRCSC The IWK Health Centre
Principal Investigator: Jerry Coleman, MB ChB FWACS Korle Bu Teaching Hospital
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allan Kember, Medical Student, IWK Health Centre
ClinicalTrials.gov Identifier: NCT02379728    
Other Study ID Numbers: GCC-S7-0629-01-10-ACC
FDA/CT/152 ( Other Identifier: Ghana Food and Drugs Authority )
First Posted: March 5, 2015    Key Record Dates
Results First Posted: April 2, 2020
Last Update Posted: April 2, 2020
Last Verified: March 2020
Keywords provided by Allan Kember, IWK Health Centre:
positional therapy
tennis ball technique
sleep pregnancy
supine position
supine
sleep position
low birth weight
stillbirth
intrauterine growth restriction
Additional relevant MeSH terms:
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Stillbirth
Fetal Growth Retardation
Fetal Hypoxia
Body Weight
Hypoxia
Birth Weight
Signs and Symptoms, Respiratory
Fetal Death
Pregnancy Complications
Death
Pathologic Processes
Fetal Diseases
Growth Disorders