Status:
UNKNOWN
Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Conditions:
Fetal Growth Retardation
Fetal Growth Complications
Eligibility:
FEMALE
18-45 years
Brief 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 feta...
Detailed Description
Background and Significance Regular exercise during pregnancy is beneficial in many ways, including decreased rates of diabetes or hypertensive disorders and decreased risks of preterm birth and cesar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06039319
Start Date
November 1 2022
End Date
June 30 2024
Last Update
September 15 2023
Active Locations (1)
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1
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States, 37920