Fetal Growth RetardationNCT06039319
Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy
An observational study of Fetal Growth Retardation and Fetal Growth Complications, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation, Fetal Growth Complications, Placental Insufficiency
- What is being tested?
- Physical activity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant individuals, between 28 weeks 0 days and 36 weeks 6 days gestational age with AGA or FGR.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 33Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
About this study
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.
Read the 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 cesarean deliveries. Many people use exercise to treat anxiety and depression as well as meet gestational weight gain recommendations. Regular exercise, defined as 150 minutes of moderate intensity exercise per week, is recommended in uncomplicated pregnancies. In some summary statements, fetal growth restriction (FGR) is noted as a relative or absolute contraindication to regular exercise. The American College of Obstetrics and Gynecology (ACOG), however, does not list FGR as a contraindication to maternal exercise. Currently, there are few high-quality studies about the effect of a recommended amount of maternal exercise on acute fetal status in pregnancies affected by FGR. The existing theories conflict. One theory is that maternal exercise will divert blood flow away from the uterus/fetus which could be deleterious in an already compromised pregnancy. The other theory is that exercise increases cardiac output and would therefore increase blood flow to the fetus. A previous study evaluated growth restricted fetuses after a single 5-minute bout of maternal exercise. This study population was heterogenous and used non-standardized measures of fetal assessment, making the results difficult to clinically interpret. In a previous study of healthy pregnancies, 30 minutes of moderate maternal exercise has been determined to have no effect on acute fetal status. The current study seeks to understand the acute fetal response to a single maternal exercise episode in pregnancies affected by FGR.
- Being tested
- Physical activity
- Medical subject headings
- Fetal Growth Retardation, Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
30 minute bout of moderate intensity physical activity performed on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| Appropriate Growth | Pregnant individuals with normal estimated fetal weight Receives: Other: Physical activity | |
| Fetal Growth Restricted | Pregnant individuals with fetal growth restriction Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre to immediately post acute exercise
Secondary outcomes (10)
Change in uterine artery dopplers from pre to post exercise
Change in physiological assessment of uterine artery dopplers measured using ultrasound
Measured: Pre to immediately post acute exercise
Change in fetal middle cerebral arterial (MCA) dopplers pulsatility index from pre to post exercise
Change in physiological assessment of fetal middle cerebral arterial (MCA) dopplers pulsatility index measured using ultrasound
Measured: Pre to immediately post acute exercise
Biophysical Profile (BPP) pre exercise
Physiological assessment of Biophysical Profile (BPP) pre exercise using ultrasound, which assesses and scores fetal wellbeing in the following areas: body movement, muscle tone, breathing movements, and amniotic fluid volume. Each component of the biophysical profile receives a score of 0-2, with a total potential score ranging from 0-8. A score of 0 reflects fetal a fetal emergency and/or ominous fetal status and a score of 8 is regarded as "reassuring" which means normal.
Measured: Pre exercise (within 1 hour of the start of acute exercise bout)
Time to complete Biophysical Profile (BPP) pre exercise
Time to complete physiological assessment of Biophysical Profile (BPP) pre exercise.
Measured: Pre exercise (within 1 hour of the start of acute exercise bout)
Biophysical Profile (BPP) post exercise
Physiological assessment of Biophysical Profile (BPP) post exercise using ultrasound, which assesses and scores fetal wellbeing in the following areas: body movement, muscle tone, breathing movements, and amniotic fluid volume. Each component of the biophysical profile receives a score of 0-2, with a total potential score ranging from 0-8. A score of 0 reflects fetal a fetal emergency and/or ominous fetal status and a score of 8 is regarded as "reassuring" which means normal.
Measured: Immediately post acute exercise
Time to complete Biophysical Profile (BPP) post exercise
Time to complete physiological assessment of Biophysical Profile (BPP).
Measured: Immediately post acute exercise
Change in blood glucose from pre to immediately post acute exercise
Change in physiological assessment of capillary blood glucose measured using glucometer
Measured: Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise
Change in blood lactate from pre to immediately post acute exercise
Change in physiological assessment of capillary blood lactate using lactate analyzer
Measured: Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise
Change in maternal mood
Change in maternal mood using the Brunel Mood Scale Questionnaire. The Brunel Mood Scale is a 32-item questionnaire of current mood descriptors, assessed via 5-point Likert scale questions ("not at all" 0 to "extremely" 4). Mood descriptors are arranged into 8 different subscales (anger, confusion, depression, fatigue, tension, vigor, happiness, calmness), which have a scoring range from 0-16. Higher scores correspond to greater presence of the subscale.
Measured: Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise
Change in maternal anxiety
Change in maternal anxiety using the State Trait Anxiety Inventory (STAI) forms Y1 (20 items) and Y2 (20 items) which assess state and trait anxiety. Each STAI item is given a weighted score of 1 to 4. Scores for both the state anxiety and trait anxiety scales can vary from a minimum of 20 to a maximum of 80, where a higher score reflects higher anxiety.
Measured: Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Nov 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039319
- Sponsor's protocol ID
- 4967
- Status last verified
- Sep 2023
- First submitted
- 11 Jul 2023
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated during and/or analyzed during the current study are not publicly available but are available from the investigators on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Maternal Exercise and the Growth Restricted Pregnancy
- ClinicalTrials.gov ID
- NCT06039319
- Acronym / sponsor ID
- 4967
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 cesarean deliveries. Many people use exercise to treat anxiety and depression as well as meet gestational weight gain recommendations. Regular exercise, defined as 150 minutes of moderate intensity exercise per week, is recommended in uncomplicated pregnancies. In some summary statements, fetal growth restriction (FGR) is noted as a relative or absolute contraindication to regular exercise. The American College of Obstetrics and Gynecology (ACOG), however, does not list FGR as a contraindication to maternal exercise. Currently, there are few high-quality studies about the effect of a recommended amount of maternal exercise on acute fetal status in pregnancies affected by FGR. The existing theories conflict. One theory is that maternal exercise will divert blood flow away from the uterus/fetus which could be deleterious in an already compromised pregnancy. The other theory is that exercise increases cardiac output and would therefore increase blood flow to the fetus. A previous study evaluated growth restricted fetuses after a single 5-minute bout of maternal exercise. This study population was heterogenous and used non-standardized measures of fetal assessment, making the results difficult to clinically interpret. In a previous study of healthy pregnancies, 30 minutes of moderate maternal exercise has been determined to have no effect on acute fetal status. The current study seeks to understand the acute fetal response to a single maternal exercise episode in pregnancies affected by FGR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appropriate Growth | – | Other: Physical activityPregnant individuals with normal estimated fetal weight |
| Fetal Growth Restricted | – | Other: Physical activityPregnant individuals with fetal growth restriction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant individuals, between 28 weeks 0 days and 36 weeks 6 days gestational age with AGA or FGR.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity30 minute bout of moderate intensity physical activity performed on a treadmill | Other | Appropriate Growth, Fetal Growth Restricted |
Primary outcome
Change in umbilical artery dopplers systolic/diastolic ratio from pre to post exercise
Time frame: Pre to immediately post acute exercise
Change in physiological assessment of umbilical artery dopplers systolic/diastolic ratio measured using ultrasound
10 secondary outcomes
Change in uterine artery dopplers from pre to post exercise
Time frame: Pre to immediately post acute exercise
Change in fetal middle cerebral arterial (MCA) dopplers pulsatility index from pre to post exercise
Time frame: Pre to immediately post acute exercise
Biophysical Profile (BPP) pre exercise
Time frame: Pre exercise (within 1 hour of the start of acute exercise bout)
Time to complete Biophysical Profile (BPP) pre exercise
Time frame: Pre exercise (within 1 hour of the start of acute exercise bout)
Biophysical Profile (BPP) post exercise
Time frame: Immediately post acute exercise
Time to complete Biophysical Profile (BPP) post exercise
Time frame: Immediately post acute exercise
Change in blood glucose from pre to immediately post acute exercise
Time frame: Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise
Change in blood lactate from pre to immediately post acute exercise
Time frame: Pre (within 1 hour of the start of acute exercise bout) to immediately post acute exercise
Change in maternal mood
Time frame: Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise
Change in maternal anxiety
Time frame: Pre (within 1 hour of the start of acute exercise bout) to 20 minutes post exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analyzed during the current study are not publicly available but are available from the investigators on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation and Fetal Growth Complications, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in umbilical artery dopplers systolic/diastolic ratio from pre to post exercise (time frame: Pre to immediately post acute exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.