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NCT06919692 | NOT YET RECRUITING | Fetal Growth Restriction

Maternal Left Lateral Position in Fetal Growth Restriction
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.

Condition or disease

Fetal Growth Restriction

Intervention/treatment

Left lateral recumbent positioning

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : SINGLE
Masking Description : The sonographer doing the fetal biometry at enrollment and during the 4-week follow-up visit will be masked to the study group assigned to the participant.
Primary Purpose : TREATMENT
Official Title : Impact of Maternal Left-Lateral Recumbent Positioning in Pregnancies With Fetal Growth Restriction
Actual Study Start Date : 2025-06-02
Estimated Primary Completion Date : 2026-06-03
Estimated Study Completion Date : 2026-12-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Maternal Left Lateral Position in Fetal Growth Restriction

Location Details

NCT06919692

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Locations

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