NCT07403994

Brief Summary

Pregnancy is a period associated with significant hormonal, physical, and emotional changes that may affect a woman's sexual function and increase sexual distress. Sexual dysfunction and related distress are common during pregnancy and may negatively impact quality of life and intimate relationships. Regular physical activity during pregnancy has been shown to improve physical well-being, emotional health, and overall quality of life. Prenatal Pilates is a commonly preferred exercise method among pregnant women and is thought to improve posture, pelvic floor muscle strength, body awareness, and stress levels. However, limited evidence exists regarding the effects of prenatal Pilates on female sexual function and sexual distress during pregnancy. This prospective observational cohort study aims to evaluate changes in female sexual function and sexual distress throughout pregnancy and to compare these changes between pregnant women who regularly participate in instructor-led prenatal Pilates and those who do not engage in structured exercise. Participants will be enrolled during the first trimester and followed across all three trimesters of pregnancy. Female sexual function will be assessed using the Female Sexual Function Index (FSFI), and sexual distress will be measured using the Female Sexual Distress Scale-Revised (FSDS-R). These questionnaires will be administered online during the first, second, and third trimesters. The study does not involve any intervention or exercise prescription; participants in the Pilates group will continue their usual prenatal Pilates activities by personal choice. The results of this study are expected to contribute to a better understanding of the relationship between prenatal physical activity and sexual health during pregnancy and may help inform future counseling and supportive care strategies for pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

January 28, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

PregnancyPrenatal PilatesFemale Sexual FunctionSexual DistressFSFIFSDS-RPhysical ActivityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Function Index (FSFI) Total Score

    The Female Sexual Function Index (FSFI) is a validated 19-item self-report questionnaire assessing female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total score ranges from 2.0 to 36.0, with higher scores indicating better sexual function. The FSFI total score will be collected via online questionnaires.

    Baseline (first trimester; 11-13 weeks' gestation), second trimester (20-24 weeks' gestation), and third trimester (32-36 weeks' gestation).

Secondary Outcomes (1)

  • Female Sexual Distress Scale-Revised (FSDS-R) Total Score

    Baseline (first trimester; 11-13 weeks' gestation), second trimester (20-24 weeks' gestation), and third trimester (32-36 weeks' gestation).

Study Arms (2)

Prenatal Pilates Group

Pregnant women who regularly participate in instructor-led prenatal Pilates during pregnancy by personal choice. Pilates sessions are performed in external Pilates studios under the supervision of certified instructors. No exercise program is prescribed, modified, or supervised by the study investigators. Participation in Pilates reflects usual lifestyle behavior.

Control Group

Pregnant women who do not participate in prenatal Pilates or any structured exercise program during pregnancy and continue their usual daily activities without engaging in organized physical exercise.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of healthy pregnant women with singleton pregnancies who are followed at a tertiary care hospital and enrolled during the first trimester of pregnancy. Participants include women who self-select to participate in instructor-led prenatal Pilates and those who do not engage in structured exercise during pregnancy.

You may qualify if:

  • Pregnant women aged 18 to 45 years
  • Singleton pregnancy
  • Enrollment during the first trimester of pregnancy (11-13 weeks' gestation)
  • Ability to read and understand Turkish
  • Willingness to participate and provide written informed consent

You may not qualify if:

  • High-risk pregnancy, including but not limited to:
  • Preeclampsia
  • Threatened preterm labor
  • Placenta previa
  • History of pelvic surgery that may affect sexual function
  • Diagnosed psychiatric disorder or current use of medications that may affect sexual function/libido
  • Incomplete questionnaire responses at any assessment time point

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University Hospital

Istanbul, Tuzla, 34947, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gökçenur Karakelleoğlu

    Istanbul Okan University Hospital, Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 11, 2026

Study Start

September 1, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to participant privacy concerns and the sensitive nature of questionnaire-based sexual health information.

Locations