Effects of Maternal Exercise on Fetal Growth Restriction
Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy
This study tests whether a single session of moderate exercise by pregnant women can improve the health of their babies when there are concerns about fetal growth restriction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Tennessee Graduate School of Medicine Academic / other |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT06039319 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the immediate effects of a single session of moderate-intensity exercise by pregnant women on fetal well-being in cases of fetal growth restriction (FGR). Fetal well-being will be assessed using biophysical profiles, non-stress tests, and umbilical artery dopplers. The study aims to clarify conflicting theories regarding whether maternal exercise is beneficial or harmful in pregnancies affected by FGR. It includes participants aged 18-45 with diagnosed FGR and those with normal fetal growth for comparison.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-45 diagnosed with fetal growth restriction between 28 to 36 weeks of gestation.
Not a fit: Patients with severe fetal growth restrictions or those outside the specified age and gestational criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safe exercise practices for pregnant women with fetal growth restrictions, potentially improving fetal health outcomes.
How similar studies have performed: While there is limited high-quality research on this specific topic, previous studies have shown mixed results regarding the effects of maternal exercise on fetal health.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 * 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
Where this trial is running
Knoxville, Tennessee
- University of Tennessee Graduate School of Medicine — Knoxville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Jill M Maples, PhD
- Email: jmaples1@utmck.edu
- Phone: 8653059367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.