Physical Acvitiy in Pregnancy

NCT07356180 | Enrolling By Invitation

• 1 other identifier: HP-00099879
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pregnant Women; Gestational Diabetes; Overweight (BMI > 25); Obese But Otherwise Healthy Participants; Gestational Diabetes Mellitus in Pregnancy

Keywords

maternal exercise; gestational diabetes; maternal physical activity; pregnancy; placental function; fetal development; maternal obesity; observational study; placental mitochondria; lifestyle intervention; pregnancy outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  At delivery

Study Arms (4)

Con

pre-pregnancy BMI 18.5-24.9, no gestational diabetes

Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)

overweight/obesity group

pre-pregnancy BMI of 25 or greater, no gestational diabetes

Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)

Gestational DM group

pre-pregnancy BMI 18.5-24.9 with gestational diabetes

Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)

gestational DM + overweight/obesity group

pre-pregnancy BMI of 25 or greater, with gestational diabetes

Behavioral: Pregnancy Physical Activity Questionnaire (PPAQ)

Interventions

Pregnancy Physical Activity Questionnaire (PPAQ) BEHAVIORAL

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.

Con; Gestational DM group; gestational DM + overweight/obesity group; overweight/obesity group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens collected during pregnancy and at delivery will be retained for analysis of placental function, including potential DNA extraction for research purposes.

MeSH Terms

Conditions

Diabetes, Gestational; Overweight; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: October 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)