Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID06919692

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

Led by University of Colorado, Denver · Updated on 2025-07-17

100

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate if resting in the maternal left-lateral position can improve fetal growth in pregnancies affected by fetal growth restriction. The study also investigates how this position affects maternal metabolomics, mental health, fetal heart function, and delivery outcomes by comparing women who use the left-lateral position to those receiving standard care without this positioning. Participants will be randomly assigned to one of two groups. One group will practice the left-lateral recumbent position daily for a total of 4 hours with a 10-minute stretching break after each hour, alongside recommendations for mild to moderate exercise 2-3 times per week and a healthy diet for 4 weeks. The other group will continue standard care with similar exercise and diet advice. Both groups will wear a smartwatch to monitor physical activity at home. A follow-up visit will occur 4 weeks after enrollment and again at delivery. Throughout the study, participants will be monitored for fetal growth using fetal biometry scans at 4 weeks, fetal cardiac function, and blood flow measurements. Maternal mental health and metabolomics will be assessed at 4 weeks and delivery. Delivery outcomes will also be recorded. The use of smartwatches will help track adherence to the intervention and physical activity levels. The total study duration for each participant includes 4 weeks of intervention followed by delivery observation.

CONDITIONS

Brief Title

Maternal Left Lateral Position in Fetal Growth Restriction

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant persons aged between 18 and 65 years
  • Diagnosis of fetal growth restriction with estimated fetal weight below the tenth percentile
  • Singleton pregnancy between 24 and 34 weeks gestational age
  • Fluency in English or Spanish language
Not Eligible

You will not qualify if you...

  • History of deep vein thrombosis, pulmonary embolism, or hypercoagulability disorder
  • Pre-pregnancy BMI greater than 40
  • Severe abnormality in umbilical artery Doppler flow, including absent or reverse end-diastolic flow
  • Receiving anticoagulation therapy
  • Suspected chromosomal anomalies or multifetal pregnancy
  • Active smoking during pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - 4 weeks

Participants practice left-lateral recumbent positioning for a total of 4 hours daily with intermittent stretching, along with mild to moderate intensity exercise 2-3 times per week and a healthy diet. Activity is recorded via a smart watch.

Daily at-home activity tracking with smart watch; periodic clinical visits as per protocol

Trial Site Locations

Total: 2 locations

1

UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

2

CU John C. Hobbins Perinatal Center

Denver, Colorado, United States, 80202

Actively Recruiting

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Research Team

H

Hannah E Vincent, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

ACOG Practice Bulletin No. 204: Fetal Growth Restriction.

American College of Obstetricians and Gynecologists' Committee on Practice Bulletins—Obstetrics and the Society forMaternal-FetalMedicin

https://pubmed.ncbi.nlm.nih.gov/30681542

Clinical Opinion: The diagnosis and management of suspected fetal growth restriction: an evidence-based approach.

Christoph C Lees, Roberto Romero, Tamara Stampalija...

https://pubmed.ncbi.nlm.nih.gov/35026129

Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging.

Hideyuki Higuchi, Shunichi Takagi, Kan Zhang...

https://pubmed.ncbi.nlm.nih.gov/25603203

The Effects of Maternal Position and Habitus on Maternal Cardiovascular Parameters as Measured by Cardiac Magnetic Resonance.

David B Nelson, Robert D Stewart, Susan A Matulevicius...

https://pubmed.ncbi.nlm.nih.gov/26375044