Maternal Left Lateral Position in Fetal Growth Restriction

NCT06919692 | Recruiting

• 1 other identifier: 25-0289
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Fetal Growth Restriction

Keywords

fetal growth restriction; left lateral position; maternal fetal medicine

Outcome Measures

Primary Outcomes (1)

• Fetal biometry

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

  4 weeks after enrollment

Secondary Outcomes (5)

• Fetal cardiac function

  4 weeks after enrollment

• Feto-Maternal Doppler flow

  4 weeks after enrollment

• Delivery outcomes

  At delivery

• Maternal Mental Health evaluation

  4 weeks after enrollment, and after delivery

• Maternal Metabolomics assessment

  4 weeks after enrollment, and after delivery

Study Arms (2)

Intervention group A

EXPERIMENTAL

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.

Behavioral: Left lateral recumbent positioning

Intervention group B

NO INTERVENTION

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.

Interventions

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.

Intervention group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

CU John C. Hobbins Perinatal Center

Denver, Colorado, 80202, United States

RECRUITING

Related Publications (13)

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics and the Society forMaternal-FetalMedicin. ACOG Practice Bulletin No. 204: Fetal Growth Restriction. Obstet Gynecol. 2019 Feb;133(2):e97-e109. doi: 10.1097/AOG.0000000000003070.

  PMID: 30681542 BACKGROUND

• Gardosi J, Madurasinghe V, Williams M, Malik A, Francis A. Maternal and fetal risk factors for stillbirth: population based study. BMJ. 2013 Jan 24;346:f108. doi: 10.1136/bmj.f108.

  PMID: 23349424 BACKGROUND

• Lees CC, Romero R, Stampalija T, Dall'Asta A, DeVore GA, Prefumo F, Frusca T, Visser GHA, Hobbins JC, Baschat AA, Bilardo CM, Galan HL, Campbell S, Maulik D, Figueras F, Lee W, Unterscheider J, Valensise H, Da Silva Costa F, Salomon LJ, Poon LC, Ferrazzi E, Mari G, Rizzo G, Kingdom JC, Kiserud T, Hecher K. Clinical Opinion: The diagnosis and management of suspected fetal growth restriction: an evidence-based approach. Am J Obstet Gynecol. 2022 Mar;226(3):366-378. doi: 10.1016/j.ajog.2021.11.1357. Epub 2022 Jan 10.

  PMID: 35026129 BACKGROUND

• Baschat AA, Galan HL, Lee W, DeVore GR, Mari G, Hobbins J, Vintzileos A, Platt LD, Manning FA. The role of the fetal biophysical profile in the management of fetal growth restriction. Am J Obstet Gynecol. 2022 Apr;226(4):475-486. doi: 10.1016/j.ajog.2022.01.020.

  PMID: 35369904 BACKGROUND

• DeVore GR, Gumina DL, Hobbins JC. Assessment of ventricular contractility in fetuses with an estimated fetal weight less than the tenth centile. Am J Obstet Gynecol. 2019 Nov;221(5):498.e1-498.e22. doi: 10.1016/j.ajog.2019.05.042. Epub 2019 May 30.

  PMID: 31153929 BACKGROUND

• DeVore GR, Polanco B, Lee W, Fowlkes JB, Peek EE, Putra M, Hobbins JC. Maternal rest improves growth in small-for-gestational-age fetuses (<10th percentile). Am J Obstet Gynecol. 2025 Jan;232(1):118.e1-118.e12. doi: 10.1016/j.ajog.2024.04.024. Epub 2024 May 21.

  PMID: 38842845 BACKGROUND

• Higuchi H, Takagi S, Zhang K, Furui I, Ozaki M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Feb;122(2):286-93. doi: 10.1097/ALN.0000000000000553.

  PMID: 25603203 BACKGROUND

• Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.

  PMID: 23059960 BACKGROUND

• Nelson DB, Stewart RD, Matulevicius SA, Morgan JL, McIntire DD, Drazner M, Cunningham FG. The Effects of Maternal Position and Habitus on Maternal Cardiovascular Parameters as Measured by Cardiac Magnetic Resonance. Am J Perinatol. 2015 Dec;32(14):1318-23. doi: 10.1055/s-0035-1563719. Epub 2015 Sep 16.

  PMID: 26375044 BACKGROUND

• Laurin J, Persson PH. The effect of bedrest in hospital on fetal outcome in pregnancies complicated by intra-uterine growth retardation. Acta Obstet Gynecol Scand. 1987;66(5):407-11. doi: 10.3109/00016348709022043.

  PMID: 3321864 BACKGROUND

• Palacio M, Mottola MF. Activity Restriction and Hospitalization in Pregnancy: Can Bed-Rest Exercise Prevent Deconditioning? A Narrative Review. Int J Environ Res Public Health. 2023 Jan 13;20(2):1454. doi: 10.3390/ijerph20021454.

  PMID: 36674214 BACKGROUND

• Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Lauder J, Sciscione A, Biggio J, Osmundson S. Society for Maternal-Fetal Medicine Consult Series #50: The role of activity restriction in obstetric management: (Replaces Consult Number 33, August 2014). Am J Obstet Gynecol. 2020 Aug;223(2):B2-B10. doi: 10.1016/j.ajog.2020.04.031. Epub 2020 Apr 29.

  PMID: 32360110 BACKGROUND

• Kovacevich GJ, Gaich SA, Lavin JP, Hopkins MP, Crane SS, Stewart J, Nelson D, Lavin LM. The prevalence of thromboembolic events among women with extended bed rest prescribed as part of the treatment for premature labor or preterm premature rupture of membranes. Am J Obstet Gynecol. 2000 May;182(5):1089-92. doi: 10.1067/mob.2000.105405.

  PMID: 10819836 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manesha Putra, MD

  University of Colorado Anschutz, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah E Vincent, PhD

CONTACT

7209191019; hannah.vincent@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)