Maternal Left Lateral Position in Fetal Growth Restriction

July 14, 2025 updated by: University of Colorado, Denver

Impact of Maternal Left-Lateral Recumbent Positioning in Pregnancies With Fetal Growth Restriction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Manesha Putra, M.D.
      • Denver, Colorado, United States, 80202
        • Recruiting
        • CU John C. Hobbins Perinatal Center
        • Contact:
        • Principal Investigator:
          • Manesha Putra, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal biometry
Time Frame: 4 weeks after enrollment
Fetal estimated fetal weight and abdominal circumference will be assessed and compared to enrollment values
4 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal cardiac function
Time Frame: 4 weeks after enrollment
Variables of fetal cardiac function including cardiac contractility and cardiac size and shape will be assessed using speckle tracking
4 weeks after enrollment
Feto-Maternal Doppler flow
Time Frame: 4 weeks after enrollment
Measures of Doppler flow including umbilical artery, middle cerebral artery, umbilical vein flow, and cerebroplacental ratio will be assessed
4 weeks after enrollment
Delivery outcomes
Time Frame: At delivery
Variables including gestational age at delivery, birthweight, neonatal arterial pH, APGAR scores, mode of delivery, indication of cesarean delivery, if applicable, will be recorded
At delivery
Maternal Metabolomics assessment
Time Frame: 4 weeks after enrollment, and after delivery
Maternal metabolomics will be evaluated and compared to baseline via a blood and a urine sample at the 4-week follow-up and via a cord blood and a maternal blood sample at the time of delivery.
4 weeks after enrollment, and after delivery
Maternal Mental Health evaluation
Time Frame: 4 weeks after enrollment, and after delivery
Maternal mental health assessment will be done via Edinburg Postnatal Depression Scale questionnaire. Based on questionnaire responses, participant will receive a score within range 0-30. A score of 10 or higher would require further evaluation for depression.
4 weeks after enrollment, and after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Manesha Putra, MD, University of Colorado Anschutz, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 28, 2025

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

December 3, 2026

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-0289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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