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Fetal Growth RestrictionNCT06919692

Maternal Left Lateral Position in Fetal Growth Restriction

A study testing Left lateral recumbent positioning in people with Fetal Growth Restriction, run by University of Colorado, Denver at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Fetal Growth Restriction
What is being tested?
Left lateral recumbent positioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
28 Jul 2025to 3 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hannah E Vincent, PhD contact

7209191019

hannah.vincent@cuanschutz.edu

United States2 sites, 2 recruiting
  • UCHealth Prenatal Diagnosis and Genetics Clinic - Anschutz Medical Campus

    Aurora, Colorado, 80045

    Hannah E Vincent, Ph.D., 720-919-1019, hannah.vincent@cuanschutz.edu

    Manesha Putra, M.D.

    Recruiting
  • CU John C. Hobbins Perinatal Center

    Denver, Colorado, 80202

    Hannah E Vincent, Ph.D., 720-919-1019, hannah.vincent@cuanschutz.edu

    Manesha Putra, M.D.

    Recruiting

Other trials in United States

About this study

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

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.
Read more

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.

Being tested
Left lateral recumbent positioning
Keywords
fetal growth restriction, left lateral position, maternal fetal medicine
Medical subject headings
Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left lateral recumbent positioningBehavioural

    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.

Study groups in NCT06919692
Study groupRoleWhat they receive
Intervention group AExperimentalPregnant 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.
Receives: Behavioral: Left lateral recumbent positioning
Intervention group BNo interventionPregnant 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fetal biometry

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

    Measured: 4 weeks after enrollment

Secondary outcomes (5)
  1. Fetal cardiac function

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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 4 weeks after enrollment, and after delivery

  5. Maternal Metabolomics assessment

    Maternal metabolomics will be evaluated and compared to baseline via a blood and a urine sample at the 4-week follow-up and via a cord blood and a maternal blood sample at the time of delivery.

    Measured: 4 weeks after enrollment, and after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start28 Jul 2025 (estimated)
  3. Primary completion3 Jun 2026 (estimated)
  4. Study completion3 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919692
Sponsor's protocol ID
25-0289
Status last verified
Jul 2025
First submitted
2 Apr 2025
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23059960
  • 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.

    PubMed 26375044
  • 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.

    PubMed 3321864
  • 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.

    PubMed 36674214
  • 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.

    PubMed 32360110
  • 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.

    PubMed 10819836

Questions about this trial

What is this clinical trial studying?

A study testing Left lateral recumbent positioning in people with Fetal Growth Restriction, run by University of Colorado, Denver at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hannah E Vincent, PhD (7209191019, hannah.vincent@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fetal biometry (time frame: 4 weeks after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06919692, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

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