Recruiting

Left-Lateral Positioning

Sponsor:

University of Colorado, Denver

Code:

NCT06919692

Conditions

Fetal Growth Restriction

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Left lateral recumbent positioning

Study Details

Brief summary:

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.

Conditions

Fetal Growth Restriction

Study ID

NCT06919692

Start date

Jul 28, 2025

Status verified date

Jul, 2025

Completion date

Dec 3, 2026

Anticipated

Primary completion date

Jun 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant persons between 18 - 65 years of age, with a diagnosis of fetal growth restriction, with an estimated fetal weight less than tenth percentile
  • Participants with a singleton pregnancy between 24- and 34-weeks' gestational age
  • Participants with fluency in English or Spanish language

Exclusion Criteria:

  • Patients with a known history of deep vein thrombosis, pulmonary embolism, or hypercoagulability disorder
  • Patients with a pre-pregnancy BMI greater than 40
  • Pregnancy with severe abnormality in umbilical artery Doppler flow, including absent end-diastolic flow (AEDF) and reverse end-diastolic flow (REDF)
  • Patients receiving anticoagulation therapy
  • Pregnancy with suspected chromosomal anomalies or a multifetal pregnancy
  • Patients with an active smoking status during pregnancy

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Left lateral recumbent positioning

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.

Primary outcome measure

  • Fetal biometry [ Time Frame: 4 weeks after enrollment ]

Central Contacts and Locations

Central contacts

Hannah E Vincent, PhD

7209191019hannah.vincent@cuanschutz.edu

Locations

UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Hannah E Vincent, Ph.D.

720-919-1019hannah.vincent@cuanschutz.edu

Principal Investigator:

Manesha Putra, M.D.

CU John C. Hobbins Perinatal Center

Recruiting

Denver, Colorado, United States, 80202

Contacts

Hannah E Vincent, Ph.D.

720-919-1019hannah.vincent@cuanschutz.edu

Principal Investigator:

Manesha Putra, M.D.

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • fetal growth restriction
  • left lateral position
  • maternal fetal medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-07-17.