NCT06919692 Maternal Left Lateral Position in Fetal Growth Restriction
| NCT ID | NCT06919692 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Fetal Growth Restriction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-28 |
| Primary Completion | 2026-06-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-28 with a primary completion date of 2026-06-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 smoking status during pregnancy
Contact & Investigator
Manesha Putra, MD
PRINCIPAL INVESTIGATOR
University of Colorado Anschutz, Department of Obstetrics and Gynecology
Frequently Asked Questions
Who can join the NCT06919692 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Fetal Growth Restriction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919692 currently recruiting?
Yes, NCT06919692 is actively recruiting participants. Contact the research team at hannah.vincent@cuanschutz.edu for enrollment information.
Where is the NCT06919692 trial being conducted?
This trial is being conducted at Aurora, United States, Denver, United States.
Who is sponsoring the NCT06919692 clinical trial?
NCT06919692 is sponsored by University of Colorado, Denver. The principal investigator is Manesha Putra, MD at University of Colorado Anschutz, Department of Obstetrics and Gynecology. The trial plans to enroll 100 participants.