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NCT Number: NCT06919692

Maternal Left Lateral Position in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Fetal biometry

    Time frame: 4 weeks after enrollment

    Fetal estimated fetal weight and abdominal circumference will be assessed and compared to enrollment values

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah E Vincent, PhD

CONTACT

[email protected]

7209191019

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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