NCT07147777

Brief Summary

This study investigates the relationship between physical activity levels and fetal health in the third trimester of pregnancy. Using the PPAQ and daily step counts, researchers will measure physical activity and examine its effects on uterine blood flow, fetal heart rate, and birth weight. The study hypothesizes that both inactivity and excessive activity may negatively impact fetal health. By focusing on overall activity levels rather than acute effects, this research aims to provide new insights to inform recommendations for a healthy pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

August 22, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

pregnancyphysical activityPPAQuterine blood flowfetal heart ratebirth weight

Outcome Measures

Primary Outcomes (3)

  • Resistance index measurement

    Systolic speed minus diastolic speed divided by systolic speed

    28-40 weeks of gestation

  • Systolic-diastolic ratio measurement

    Systolic value divided by diastolic value on ultrasound

    28-40 weeks of gestation

  • Fetal hearth rate measurement

    Fetal heart rate measured during sonographic obstetric evaluation of the fetus

    28-40 weeks of gestation

Secondary Outcomes (1)

  • Baby's birth weight measurement

    Day of delivery

Study Arms (3)

Inactive group

Pregnant women will be divided into three categories based on the distribution of their PPAQ scores: the bottom 33% (inactive group), the middle 33% (moderately active group), and the top 33% (overactive group).

Moderately active group

Pregnant women will be divided into three categories based on the distribution of their PPAQ scores: the bottom 33% (inactive group), the middle 33% (moderately active group), and the top 33% (overactive group).

Overactive group

Pregnant women will be divided into three categories based on the distribution of their PPAQ scores: the bottom 33% (inactive group), the middle 33% (moderately active group), and the top 33% (overactive group).

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy participants are limited to pregnant women, which requires female biological sex.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients were selected by systematic random sampling method among pregnant women who applied to the obstetrics clinic and were in the last trimester of their pregnancy (28th week and following weeks).

You may qualify if:

  • Singleton pregnancy
  • ≥28 gestational weeks (confirmed by ultrasound)
  • Willing and able to participate; provides written informed consent
  • Owns a mobile phone capable of step-count data collection

You may not qualify if:

  • Multiple pregnancy
  • History of miscarriage in previous pregnancies
  • Chronic systemic disease (e.g., diabetes, hypertension, thyroid disease)
  • Detection of fetal anomalies
  • Drug or substance abuse
  • Current cigarette smoking
  • Serious psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya City Hospital, Antalya Anatolia Hospital

Antalya, 07080, Turkey (Türkiye)

Location

Related Publications (6)

  • Köken G, Yılmazer M. Gebelik ve Egzersiz. Turkiye Klinikleri J Gynecol Obst. 2007;17:385-92.

    BACKGROUND
  • Cirak Y, Yilmaz GD, Demir YP, Dalkilinc M, Yaman S. Pregnancy physical activity questionnaire (PPAQ): reliability and validity of Turkish version. J Phys Ther Sci. 2015 Dec;27(12):3703-9. doi: 10.1589/jpts.27.3703. Epub 2015 Dec 28.

    PMID: 26834336BACKGROUND
  • Park S, Marcotte R, Staudenmayer J, Sirard J, VanKim N, Pekow P, Strath S, Freedson P, Chasan-Taber L. Validity of the Pregnancy Physical Activity Questionnaire Short Form (PPAQ-SF). Am J Epidemiol. 2024 Oct 2:kwae382. doi: 10.1093/aje/kwae382. Online ahead of print.

    PMID: 39359005BACKGROUND
  • Fernandez-Buhigas I, Martin Arias A, Vargas-Terrones M, Brik M, Rolle V, Barakat R, Munoz-Gonzalez MD, Refoyo I, Gil MM, Santacruz B. Fetal and maternal Doppler adaptation to maternal exercise during pregnancy: a randomized controlled trial. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2183759. doi: 10.1080/14767058.2023.2183759.

    PMID: 36889747BACKGROUND
  • Sussman D, Saini BS, Schneiderman JE, Spitzer R, Seed M, Lye SJ, Wells GD. Uterine artery and umbilical vein blood flow are unaffected by moderate habitual physical activity during pregnancy. Prenat Diagn. 2019 Oct;39(11):976-985. doi: 10.1002/pd.5517. Epub 2019 Jul 29.

    PMID: 31254464BACKGROUND
  • Nguyen NC, Evenson KR, Savitz DA, Chu H, Thorp JM, Daniels JL. Physical activity and maternal-fetal circulation measured by Doppler ultrasound. J Perinatol. 2013 Feb;33(2):87-93. doi: 10.1038/jp.2012.68. Epub 2012 Jun 7.

    PMID: 22678142BACKGROUND

MeSH Terms

Conditions

Motor ActivityBirth Weight

Condition Hierarchy (Ancestors)

BehaviorBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erhan Muluk, MD

    Antalya Anatolia Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 29, 2025

Study Start

August 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 15, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The de-identified individual participant data (IPD) from this study, along with the study protocol and statistical analysis plan, will be made available to researchers who provide a methodologically sound proposal. The data will be shared after publication of the main results, through a secure platform, for a period of up to 5 years.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
5 years
Access Criteria
De-identified individual participant data will be made available to researchers who provide a methodologically sound and ethically approved research proposal. Data will be shared via a secure, designated platform, and a data use agreement will be required to ensure compliance with privacy and ethical standards.
More information

Locations