Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-02 @ 8:32 AM
Study NCT ID:
NCT06919692
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Left Lateral Position in Fetal Growth Restriction
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Impact of Maternal Left-Lateral Recumbent Positioning in Pregnancies With Fetal Growth Restriction
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: