- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07356180
Physical Acvitiy in Pregnancy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Con
pre-pregnancy BMI 18.5-24.9,
no gestational diabetes
|
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. |
|
overweight/obesity group
pre-pregnancy BMI of 25 or greater, no gestational diabetes
|
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. |
|
Gestational DM group
pre-pregnancy BMI 18.5-24.9
with gestational diabetes
|
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. |
|
gestational DM + overweight/obesity group
pre-pregnancy BMI of 25 or greater, with gestational diabetes
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At delivery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Nutrition Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Metabolic Diseases
- Overnutrition
- Body Weight
- Pregnancy Complications
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Obesity
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Diabetes, Gestational
- Pregnancy in Obesity
Other Study ID Numbers
- HP-00099879
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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