Pregnant WomenNCT07356180
Physical Acvitiy in Pregnancy
An observational study of Pregnant Women and Gestational Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this observational study is to learn how a physically active lifestyle during pregnancy affects placental development and function. The main question it aims to answer is: Does regular physical activity during pregnancy improve placental function and support healthy fetal growth? Pregnant participants will… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnant Women, Gestational Diabetes, Obese But Otherwise Healthy Participants
- What is being tested?
- Pregnancy Physical Activity Questionnaire (PPAQ)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to Dec 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Study population: The study population consists of pregnant individuals receiving prenatal care and/or delivering at affiliated clinical sites of the University of Maryland, Baltimore and surrounding community healthcare settings. Participants will be recruited from local obstetric clinics and hospital-based prenatal care programs. The study represents a community-based sample of pregnant individuals with varying levels of physical activity during pregnancy.
Who may be able to join
- Pregnant female and their newborn infant(s)
- Aged 18-45 (pregnant female), age 0-60 days of life (newborn infant)
- English speaking
- Screened for gestational diabetes with standard glucose tolerance test between 24w - 41w gestation
- Delivered at gestational age 34week-41weeks
- Delivered via non-emergent Cesarean section during weekday hours
- No known infectious disease (ex: HIV, HepC)
Who cannot join
- Women <18yo or >45yo
- Non-English speaking
- Pre-existing diabetes or diagnosed with diabetes prior to 24weeks
- Required complex diets/supplements not related to the pregnancy (i.e. malnutrition)
- Known severe fetal anomalies or genetic disorder
- Placenta accreta spectrum
- Emergent cesarean delivery performed due to fetal distress
- Known infectious disease (ex: HIV, HepC)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland Medical System
Baltimore, Maryland, 21201
About this study
Official title: Epigenetic Regulation of Physically Active Lifestyle on Placental Development
The goal of this observational study is to learn how a physically active lifestyle during pregnancy affects placental development and function. The main question it aims to answer is:
Does regular physical activity during pregnancy improve placental function and support healthy fetal growth?
Pregnant participants will provide biological samples and health information during pregnancy and at delivery. The study will use these samples to examine how activity levels relate to placental energy production and overall health.
Read the detailed description
This observational study aims to examine how a physically active lifestyle during pregnancy affects placental function and fetal development. We will enroll pregnant participants and collect biological samples, including blood and placental tissue after delivery. The study will measure markers of placental energy production and other indicators of placental health to understand the mechanisms by which maternal physical activity may influence fetal growth.
Data collected will also include health information, lifestyle questionnaires, and activity assessments during pregnancy. Participants will not need to change their normal exercise habits. The results of this study may help identify how maternal physical activity supports placental and fetal health, which could inform future recommendations for healthy pregnancies.
- Conditions
- Pregnant Women, Gestational Diabetes, Obese But Otherwise Healthy Participants, Overweight (BMI > 25), Gestational Diabetes Mellitus in Pregnancy
- Being tested
- Pregnancy Physical Activity Questionnaire (PPAQ)
- Keywords
- maternal exercise, gestational diabetes, maternal physical activity, pregnancy, placental function, fetal development, maternal obesity, observational study, placental mitochondria, lifestyle intervention, pregnancy outcomes
- Medical subject headings
- Diabetes, Gestational, Overweight, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy Physical Activity Questionnaire (PPAQ)Behavioural
The PPAQ is a semiquantitative questionnaire that asks respondents to report the time spent participating in 32 activities including household/caregiving (13 activities),occupational (5 activities), sports/exercise (8 activities), transportation (3 activities), and inactivity (3 activities).
For each activity, respondents are asked to select the category that best approximates the amount of time spent in that activity per day or week during the currenttrimester. Possible durations range from 0 to 6 or more hours per day and from 0 to 3 or more hours per week.
| Study group | Role | What they receive |
|---|---|---|
| Con | pre-pregnancy BMI 18.5-24.9, no gestational diabetes Receives: Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ) | |
| overweight/obesity group | pre-pregnancy BMI of 25 or greater, no gestational diabetes Receives: Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ) | |
| Gestational DM group | pre-pregnancy BMI 18.5-24.9 with gestational diabetes Receives: Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ) | |
| gestational DM + overweight/obesity group | pre-pregnancy BMI of 25 or greater, with gestational diabetes Receives: Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental mitochondrial function
Placental mitochondrial function will be assessed using markers of mitochondrial biogenesis and energy metabolism measured in placental tissue collected at delivery. Outcomes will be examined in relation to maternal physical activity levels during pregnancy.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start18 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Seok Son, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356180
- Sponsor's protocol ID
- HP-00099879
- Status last verified
- Dec 2025
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of our study will not be shared with the subjects. We plan on publishing our results in a peer reviewed journal. We also plan to present the results as a thesis dissertation for Dr. Esteves. We also hope the results will generate evidence for benefits of physical activity during pregnancy, which will lead to seeking extramural NIH grants for cohort study of pregnant women with exercise programs.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Regulation of Physically Active Lifestyle on Placental Development
- ClinicalTrials.gov ID
- NCT07356180
- Acronym / sponsor ID
- HP-00099879
- Conditions
- Pregnant Women, Gestational Diabetes, Obese But Otherwise Healthy Participants, Overweight (BMI > 25), Gestational Diabetes Mellitus in Pregnancy
- Keywords
- maternal exercise, gestational diabetes, maternal physical activity, pregnancy, placental function, fetal development, maternal obesity, observational study
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jan 2026 (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.
The goal of this observational study is to learn how a physically active lifestyle during pregnancy affects placental development and function. The main question it aims to answer is:
Does regular physical activity during pregnancy improve placental function and support healthy fetal growth?
Pregnant participants will provide biological samples and health information during pregnancy and at delivery. The study will use these samples to examine how activity levels relate to placental energy production and overall health.
Detailed description
This observational study aims to examine how a physically active lifestyle during pregnancy affects placental function and fetal development. We will enroll pregnant participants and collect biological samples, including blood and placental tissue after delivery. The study will measure markers of placental energy production and other indicators of placental health to understand the mechanisms by which maternal physical activity may influence fetal growth.
Data collected will also include health information, lifestyle questionnaires, and activity assessments during pregnancy. Participants will not need to change their normal exercise habits. The results of this study may help identify how maternal physical activity supports placental and fetal health, which could inform future recommendations for healthy pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Con | – | Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)pre-pregnancy BMI 18.5-24.9, no gestational diabetes |
| overweight/obesity group | – | Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)pre-pregnancy BMI of 25 or greater, no gestational diabetes |
| Gestational DM group | – | Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)pre-pregnancy BMI 18.5-24.9 with gestational diabetes |
| gestational DM + overweight/obesity group | – | Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)pre-pregnancy BMI of 25 or greater, with gestational diabetes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of pregnant individuals receiving prenatal care and/or delivering at affiliated clinical sites of the University of Maryland, Baltimore and surrounding community healthcare settings. Participants will be recruited from local obstetric clinics and hospital-based prenatal care programs. The study represents a community-based sample of pregnant individuals with varying levels of physical activity during pregnancy.
Key inclusion criteria (7 listed)
- Pregnant female and their newborn infant(s)
- Aged 18-45 (pregnant female), age 0-60 days of life (newborn infant)
- English speaking
- Screened for gestational diabetes with standard glucose tolerance test between 24w - 41w gestation
- Delivered at gestational age 34week-41weeks
Key exclusion criteria (8 listed)
- Women <18yo or >45yo
- Non-English speaking
- Pre-existing diabetes or diagnosed with diabetes prior to 24weeks
- Required complex diets/supplements not related to the pregnancy (i.e. malnutrition)
- Known severe fetal anomalies or genetic disorder
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 |
|---|---|---|
| Pregnancy Physical Activity Questionnaire (PPAQ)The PPAQ is a semiquantitative questionnaire that asks respondents to report the time spent participating in 32 activities including household/caregiving (13 activities),occupational (5 activities), sports/exercise (8 activities), transportation (3 activities), and inactivity (3 activities). For each activity, respondents are asked to select the category that best approximates the amount of time spent in that activity per day or week during the currenttrimester. Possible durations range from 0 to 6 or more hours per day and from 0 to 3 or more hours per week. | Behavioural | Con, Gestational DM group, gestational DM + overweight/obesity group, overweight/obesity group |
Primary outcome
Placental mitochondrial function
Time frame: At delivery
Placental mitochondrial function will be assessed using markers of mitochondrial biogenesis and energy metabolism measured in placental tissue collected at delivery. Outcomes will be examined in relation to maternal physical activity levels during pregnancy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. Results of our study will not be shared with the subjects. We plan on publishing our results in a peer reviewed journal. We also plan to present the results as a thesis dissertation for Dr. Esteves. We also hope the results will generate evidence for benefits of physical activity during pregnancy, which will lead to seeking extramural NIH grants for cohort study of pregnant women with exercise programs.
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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.
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 Pregnant Women and Gestational Diabetes, run by University of Maryland, Baltimore 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 7 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 21 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
Placental mitochondrial function (time frame: At delivery). 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 21 Jan 2026.