RECRUITING

Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy

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Conditions

Fetal Growth RetardationFetal Growth ComplicationsPlacental Insufficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy

Quick Facts

Study Start:2022-11-01
Study Completion:2024-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06039319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Inclusion Criteria - FGR population
  2. * Age 18-45
  3. * 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
  4. * Diagnosis of FGR at any point in gestation (preference given for inclusion of those diagnosed with FGR after 32w0d)
  5. * 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)
  6. * Compliant with standard prenatal care
  7. * Age 18-45
  8. * Intrauterine pregnancy with normal estimated fetal growth (EFW \>10%ile and \<90%ile)
  9. * 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)
  10. * Compliant with standard prenatal care
  1. * Exclusion Criteria - FGR population
  2. * Known contraindication to completion of 30 minutes of moderate intensity exercise
  3. * Fetal umbilical artery with elevated S/D ratio or absent or reversed diastolic flow
  4. * BMI \>40
  5. * Severe maternal anemia (Hb less than 8.0)
  6. * Placenta previa
  7. * 2nd or 3rd trimester vaginal bleeding
  8. * Preterm premature rupture of membranes
  9. * Cervical insufficiency
  10. * Multi-fetal gestation
  11. * Oligohydramnios
  12. * Hypertensive disorder requiring antihypertensive medication
  13. * Blood pressure \>140/90 on the day of the study visit prior to exercise
  14. * Tobacco use
  15. * Opioid agonist therapy
  16. * Known fetal chromosomal anomaly, structural anomaly or infection
  17. * Inability or unwillingness of subject to give informed consent
  18. * Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principle investigators
  19. * Known contraindication to completion of 30 minutes of moderate intensity exercise
  20. * BMI \>40
  21. * Severe maternal anemia (Hb less than 8.0)
  22. * Placenta previa
  23. * 2nd or 3rd trimester vaginal bleeding
  24. * Preterm premature rupture of membranes
  25. * Cervical insufficiency
  26. * Multi-fetal gestation
  27. * Oligohydramnios
  28. * Hypertensive disorder requiring antihypertensive medication
  29. * Blood pressure \>140/90 on the day of the study visit prior to exercise
  30. * Tobacco use
  31. * Opioid agonist therapy
  32. * Known fetal chromosomal anomaly, structural anomaly or infection
  33. * Inability or unwillingness of subject to give informed consent
  34. * Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principle investigators

Contacts and Locations

Study Contact

Jill M Maples, PhD
CONTACT
8653059367
jmaples1@utmck.edu

Study Locations (Sites)

University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
United States

Collaborators and Investigators

Sponsor: University of Tennessee Graduate School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2024-06-30

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2024-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Fetal Growth Retardation
  • Fetal Growth Complications
  • Placental Insufficiency