Maternal Left Lateral Position in Fetal Growth Restriction

Not Applicable

Not yet recruiting

• Conditions: Fetal Growth Restriction

• Registration Number: NCT06919692
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Start: 2025-06-02
• Primary Completion: 2026-06-03
• Study Completion: 2026-12-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 status during pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fetal biometry	4 weeks after enrollment	Fetal estimated fetal weight and abdominal circumference will be assessed and compared to enrollment values

Secondary Outcome Measures

Name	Time	Method
Fetal cardiac function	4 weeks after enrollment	Variables of fetal cardiac function including cardiac contractility and cardiac size and shape will be assessed using speckle tracking
Feto-Maternal Doppler flow	4 weeks after enrollment	Measures of Doppler flow including umbilical artery, middle cerebral artery, umbilical vein flow, and cerebroplacental ratio will be assessed
Delivery outcomes	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
Maternal Mental Health evaluation	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.
Maternal Metabolomics assessment	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.