Maternal Left Lateral Position in Fetal Growth Restriction
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT06919692
- Status
- Recruiting
Conditions
- Fetal Growth Restriction
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Left lateral recumbent positioning — BEHAVIORALLeft-lateral position is the recommended position of resting in pregnancy. The participants in the intervention group will be advised to practice this position with an intermittent 10-minute stretching after every hour of resting, with no more than 4-hours of this intervention per day.
Study Details
The goal of this clinical trial is to learn if maternal left-lateral positioning in pregnancy works to treat fetal growth restriction. This study will also help us learn about the effects of left-lateral positioning on maternal metabolomics, maternal mental health, fetal cardiac function, and delivery outcomes. The main questions it aims to answer are: * Does maternal left-lateral position in a pregnancy with fetal growth restriction improve the baby's growth? * How are maternal metabolomics, delivery outcomes, maternal mental health, and fetal cardiac function impacted by maternal left-lateral position? Researchers will compare the intervention group to pregnancies with fetal growth restriction that receive standard of care (without left-lateral positioning) to see if left-lateral position improves fetal biometry in fetal growth restriction. Participants will: * Practice left-lateral position every day for 4 hours (cumulatively) with 10-mins stretching after every hour of left-lateral position, or continue to receive standard of care * Visit the clinic once after 4 weeks for a follow-up research visit, and at the time of delivery Tracking of the physical activity and adherence to left-lateral position at home in intervention group A will be done through a fitbit (smart watch) given during enrollment. A fitbit will also be given to participants in intervention group B, receiving standard of care, to monitor their physical activity trends at home.
Key Dates
- Start date
- Jul 28, 2025
- Status verified
- Jul 2025
- Primary completion
- Jun 3, 2026
- Completion
- Dec 3, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention group APregnant persons randomized into this group will be instructed to practice left-lateral recumbent position for a period of 4-hours (cumulatively) daily for 4-weeks after enrollment. The participants will be advised to stretch for 10 mins after every hour of recumbent position. A per-protocol recommendation of mild to moderate intensity exercise 2-3 times a week will be advised. A healthy diet will also be recommended. The activity at home will be recorded via a smart watch.
- No Intervention: Intervention group BPregnant persons in this group will continue to receive the 'standard of care', per clinical protocol. A recommendation of mild to moderate intensity exercise 2-3 times a week will be advised. A healthy diet will be recommended. The activity status at home will be recorded via a smart watch.
Primary Outcome Measure
Fetal biometry [ Time Frame: 4 weeks after enrollment ]
Central Contacts
- Hannah E Vincent, PhD7209191019
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus | Aurora | Colorado | 80045 | Manesha Putra, M.D. (PRINCIPAL_INVESTIGATOR) |
| CU John C. Hobbins Perinatal Center | Denver | Colorado | 80202 | Manesha Putra, M.D. (PRINCIPAL_INVESTIGATOR) |
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