Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy

NCT06039319 | Completed

• 1 other identifier: 4967
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Fetal Growth Retardation; Fetal Growth Complications; Placental Insufficiency

Outcome Measures

Primary Outcomes (1)

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

  Change in physiological assessment of umbilical artery dopplers systolic/diastolic ratio measured using ultrasound

  Pre to immediately post acute exercise

Secondary Outcomes (10)

• Change in uterine artery dopplers from pre to post exercise

  Pre to immediately post acute exercise

• Change in fetal middle cerebral arterial (MCA) dopplers pulsatility index from pre to post exercise

  Pre to immediately post acute exercise

• Biophysical Profile (BPP) pre exercise

  Pre exercise (within 1 hour of the start of acute exercise bout)

• Time to complete Biophysical Profile (BPP) pre exercise

  Pre exercise (within 1 hour of the start of acute exercise bout)

• Biophysical Profile (BPP) post exercise

  Immediately post acute exercise

Study Arms (2)

Appropriate Growth

Pregnant individuals with normal estimated fetal weight

Other: Physical activity

Fetal Growth Restricted

Pregnant individuals with fetal growth restriction

Other: Physical activity

Interventions

Physical activity OTHER

30 minute bout of moderate intensity physical activity performed on a treadmill

Appropriate Growth; Fetal Growth Restricted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant individuals, between 28 weeks 0 days and 36 weeks 6 days gestational age with AGA or FGR.

You may qualify if:

• 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
• 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
• 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:

• 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
• nd 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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Fetal Growth Retardation; Placental Insufficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Placenta Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: September 15, 2023
• Study Start: November 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 3, 2026

Record last verified: 2023-09

Locations

US (1)