Maternal Left Lateral Position in Fetal Growth Restriction

University of Colorado Denver (CU Denver)

Status: Begins enrollment this month

Conditions: Fetal Growth Restriction

Treatments: Behavioral: Left lateral recumbent positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06919692

25-0289

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention group A

Experimental group

Description:

Pregnant persons randomized into this group will be instructed to practice left-lateral recumbent position for a period of 4-hours (cumulatively) daily for 4-weeks after enrollment. The participants will be advised to stretch for 10 mins after every hour of recumbent position. A per-protocol recommendation of mild to moderate intensity exercise 2-3 times a week will be advised. A healthy diet will also be recommended. The activity at home will be recorded via a smart watch.

Treatment:

Behavioral: Left lateral recumbent positioning

Intervention group B

No Intervention group

Description:

Pregnant persons in this group will continue to receive the 'standard of care', per clinical protocol. A recommendation of mild to moderate intensity exercise 2-3 times a week will be advised. A healthy diet will be recommended. The activity status at home will be recorded via a smart watch.