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Maternal Left Lateral Position in Fetal Growth Restriction

ConditionFetal Growth Restriction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Colorado, Denver

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Left lateral recumbent positioning

    Behavioral

    Left-lateral position is the recommended position of resting in pregnancy. The participants in the intervention group will be advised to practice this position with an intermittent 10-minute stretching after every hour of resting, with no more than 4-hours of this intervention per day.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention group AExperimental treatment 1 intervention
Group B: Intervention group BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Fetal biometry

Fetal estimated fetal weight and abdominal circumference will be assessed and compared to enrollment values

Time frame
4 weeks after enrollment

Secondary outcomes

1

Fetal cardiac function

Variables of fetal cardiac function including cardiac contractility and cardiac size and shape will be assessed using speckle tracking

Time frame
4 weeks after enrollment
2

Feto-Maternal Doppler flow

Measures of Doppler flow including umbilical artery, middle cerebral artery, umbilical vein flow, and cerebroplacental ratio will be assessed

Time frame
4 weeks after enrollment
3

Delivery outcomes

Variables including gestational age at delivery, birthweight, neonatal arterial pH, APGAR scores, mode of delivery, indication of cesarean delivery, if applicable, will be recorded

Time frame
At delivery
4

Maternal Mental Health evaluation

Maternal mental health assessment will be done via Edinburg Postnatal Depression Scale questionnaire. Based on questionnaire responses, participant will receive a score within range 0-30. A score of 10 or higher would require further evaluation for depression.

Time frame
4 weeks after enrollment, and after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Source ClinicalTrials.gov
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