Clinical trial NCT06919692: Maternal Left Lateral Position in Fetal Growth Restriction
Official title: Impact of Maternal Left-Lateral Recumbent Positioning in Pregnancies With Fetal Growth Restriction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fetal Growth Restriction
Keywords: fetal growth restriction
left lateral position
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fetal biometry
timeFrame: 4 weeks after enrollment
Secondary outcomes:
measure: Fetal cardiac function
timeFrame: 4 weeks after enrollment
measure: Feto-Maternal Doppler flow
timeFrame: 4 weeks after enrollment
measure: Delivery outcomes
timeFrame: At delivery
measure: Maternal Mental Health evaluation
timeFrame: 4 weeks after enrollment, and after delivery
measure: Maternal Metabolomics assessment
timeFrame: 4 weeks after enrollment, and after delivery
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado Anschutz, Department of Obstetrics and Gynecology
name: Manesha Putra, MD
role: PRINCIPAL_INVESTIGATOR
References:
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