CompletedNot Applicable

Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy

United States40 participantsStarted 2022-11-01

Plain-language summary

Objectives / Specific Aims * The purpose of this study is to investigate the acute effects of a single bout of moderate intensity maternal exercise on fetal well-being in a pregnancy affected by fetal growth restriction. Fetal well-being will be measured by biophysical profile (BPP), non-stress test (NST) and umbilical artery dopplers. * The hypothesis is that a single bout of maternal exercise will not significantly alter fetal well-being or fetal status.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inclusion Criteria - FGR population * Age 18-45 * Intrauterine pregnancy with diagnosis of fetal growth restriction (FGR) as defined by total estimated fetal weight \<10%ile for EGA or abdominal circumference \<10%ile for EGA * Diagnosis of FGR at any point in gestation (preference given for inclusion of those diagnosed with FGR after 32w0d) * Gestational age between 28w0d and 36w6d at time of intervention (based on sure last menstrual period (LMP) confirmed by first or second trimester ultrasound or unsure LMP with first trimester ultrasound) * Compliant with standard prenatal care Inclusion Criteria - Average for gestational age (AGA) population * Age 18-45 * Intrauterine pregnancy with normal estimated fetal growth (EFW \>10%ile and \<90%ile) * Gestational age between 28w0d and 36w6d at time of intervention with accurate dating (based on sure LMP confirmed by ultrasound prior to 22 weeks or unsure LMP with first trimester ultrasound) * Compliant with standard prenatal care Exclusion Criteria: * Exclusion Criteria - FGR population * Known contraindication to completion of 30 minutes of moderate intensity exercise * Fetal umbilical artery with elevated S/D ratio or absent or reversed diastolic flow * BMI \>40 * Severe maternal anemia (Hb less than 8.0) * Placenta previa * 2nd or 3rd trimester vaginal bleeding * Preterm premature rupture of membranes * Cervical insufficiency * Multi-fetal gestation * Oligohydramnios …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in umbilical artery dopplers systolic/diastolic ratio from pre to post exercise

Timeframe: Pre to immediately post acute exercise

Trial details

NCT IDNCT06039319

SponsorUniversity of Tennessee Graduate School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Fetal Growth Retardation trials