Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy
Completed
Conditions studied: Fetal Growth Retardation, Fetal Growth Complications, Placental Insufficiency
In brief
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.
Key facts
- Study ID
- NCT06039319
- Run by
- University of Tennessee Graduate School of Medicine
- People needed
- 40
- Starts
- 2022-11-01
- Expected to finish
- 2024-06-30
- Last updated by the study team
- 2026-02-03
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Hypertensive disorder requiring antihypertensive medication
- Blood pressure >140/90 on the day of the study visit prior to exercise
- Tobacco use
- Opioid agonist therapy
- Known fetal chromosomal anomaly, structural anomaly or infection
- Inability or unwillingness of subject to give informed consent
- Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principle investigators
- Exclusion Criteria - AGA population
- Known contraindication to completion of 30 minutes of moderate intensity exercise
- BMI >40
- Severe maternal anemia (Hb less than 8.0)
- Placenta previa
- 2nd or 3rd trimester vaginal bleeding
- Preterm premature rupture of membranes
Where it is running
- University of Tennessee Graduate School of Medicine — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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