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 — BEHAVIORAL
    Left-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 A
    Pregnant 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 B
    Pregnant 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

Locations (2)

FacilityCityStateZIPSite coordinators
UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical CampusAuroraColorado80045
Hannah E Vincent, Ph.D.
720-919-1019
Manesha Putra, M.D. (PRINCIPAL_INVESTIGATOR)
CU John C. Hobbins Perinatal CenterDenverColorado80202
Hannah E Vincent, Ph.D.
720-919-1019
Manesha Putra, M.D. (PRINCIPAL_INVESTIGATOR)

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