Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
Sleep, Pregnancy, Stillbirth
About this trial
This is an interventional treatment trial for Sleep focused on measuring positional therapy, tennis ball technique, sleep pregnancy, supine position, supine, sleep position, low birth weight, stillbirth, intrauterine growth restriction
Eligibility 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
Sites / Locations
- Korle Bu Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Sham Comparator
Sham Comparator
PrenaBelt
PrenaBelt with Body Position Sensor
Control
Control with Body Position Sensor (BPS)
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.
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.
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.
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.