Maternal Left Lateral Position in Fetal Growth Restriction

Официальное название

Impact of Maternal Left-Lateral Recumbent Positioning in Pregnancies With Fetal Growth Restriction

Обзор

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.

Вмешательства

• Поведенческое Left lateral recumbent positioning
  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.

Первичные конечные точки

• Fetal biometry [Срок оценки: 4 weeks after enrollment]

Вторичные конечные точки (5)

• Fetal cardiac function [Срок оценки: 4 weeks after enrollment]
• Feto-Maternal Doppler flow [Срок оценки: 4 weeks after enrollment]
• Delivery outcomes [Срок оценки: At delivery]
• Maternal Mental Health evaluation [Срок оценки: 4 weeks after enrollment, and after delivery]
• Maternal Metabolomics assessment [Срок оценки: 4 weeks after enrollment, and after delivery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus — Aurora
• CU John C. Hobbins Perinatal Center — Denver

Публикации

• 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
• 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
• 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 evi PMID 35026129
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06919692 · 25-0289

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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