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Female Sexual Function During PregnancyPP-SEXNCT07403994

Prenatal Pilates and Sexual Function During Pregnancy

An observational study of Female Sexual Function During Pregnancy and Pregnancy, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
How many people
136 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2025to 15 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Okan University Hospital

    Istanbul, Tuzla, 34947

Other trials in Turkey (Türkiye)

About this study

Official title: The Longitudinal Impact of Prenatal Pilates on Female Sexual Function and Sexual Distress During Pregnancy

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.

Read more

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.

Read the detailed description

Pregnancy is accompanied by substantial physiological, hormonal, and psychosocial changes that may influence female sexual function and contribute to increased sexual distress. Alterations in body image, fatigue, hormonal fluctuations, and emotional well-being during pregnancy have been associated with decreased sexual desire, arousal, and satisfaction. Despite the high prevalence of sexual dysfunction during pregnancy, this topic remains under-discussed in routine antenatal care.

Physical activity during pregnancy has been associated with multiple maternal benefits, including improved musculoskeletal function, reduced stress, and enhanced quality of life. Prenatal Pilates is a low-impact exercise modality that focuses on posture, breathing, pelvic floor muscle activation, core stabilization, and flexibility. It is commonly practiced by pregnant women and is considered safe when performed under the supervision of a certified instructor. While prenatal Pilates has been shown to improve physical comfort and psychological well-being, evidence regarding its association with female sexual function and sexual distress during pregnancy remains limited.

This study is designed as a prospective observational cohort study conducted at a single tertiary care center. Pregnant women with singleton pregnancies will be enrolled during the first trimester and followed longitudinally throughout pregnancy. Participants will be categorized into two groups based on their self-reported exercise behavior: those who regularly participate in instructor-led prenatal Pilates and those who do not engage in structured exercise during pregnancy. No exercise intervention or behavioral modification will be introduced as part of the study protocol.

Data will be collected using validated, self-administered questionnaires delivered through secure online platforms during the first, second, and third trimesters of pregnancy. Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a 19-item instrument evaluating six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Sexual distress will be measured using the Female Sexual Distress Scale-Revised (FSDS-R), a 13-item questionnaire assessing sexually related personal distress. Higher FSFI scores indicate better sexual function, whereas higher FSDS-R scores reflect greater sexual distress.

Demographic and obstetric characteristics, including maternal age, parity, gestational age, and relevant medical history, will be collected at baseline. The primary objective of the study is to evaluate longitudinal changes in FSFI and FSDS-R scores across pregnancy. Secondary objectives include comparing temporal patterns of sexual function and distress between the prenatal Pilates and non-exercising groups.

Statistical analyses will be performed using appropriate longitudinal analytical methods. Within-group changes across trimesters will be assessed using repeated-measures analyses, while between-group differences over time will be evaluated using mixed-effects models or equivalent generalized linear modeling approaches, depending on data distribution. These analyses aim to account for both time-dependent changes and group-level differences.

This study seeks to provide further insight into the relationship between prenatal physical activity and sexual health during pregnancy. By examining sexual function and distress longitudinally, the findings may support more comprehensive counseling approaches and contribute to the growing body of evidence regarding non-pharmacological strategies to support sexual well-being during pregnancy.

Keywords
Pregnancy, Prenatal Pilates, Female Sexual Function, Sexual Distress, FSFI, FSDS-R, Physical Activity, Quality of Life
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07403994
Study groupRoleWhat they receive
Prenatal Pilates GroupPregnant 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 GroupPregnant 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Female Sexual Distress Scale-Revised (FSDS-R) Total Score

    The Female Sexual Distress Scale-Revised (FSDS-R) is a validated 13-item self-report questionnaire designed to assess sexually related personal distress in women. The FSDS-R total score ranges from 0 to 52, with higher scores indicating greater sexual distress. The FSDS-R total score will be collected via online questionnaires.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start1 Sep 2025
  3. Primary completion15 Mar 2026
  4. Study completion15 Mar 2026

Resources

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
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07403994
Sponsor's protocol ID
OKAN-PP-FSFI-2025
Acronym
PP-SEX
Status last verified
Jul 2026
First submitted
28 Jan 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to participant privacy concerns and the sensitive nature of questionnaire-based sexual health information.

Publications

  • Karakelleoglu G, Guclu M, Kirimli Yanik ECN, Arslan G, Ozgen D, Guzel Y. Supervised prenatal Pilates and trajectories of female sexual function and sexual distress throughout pregnancy: a prospective cohort study. J Sex Med. 2026 Sep 14;23(10):qdag315. doi: 10.1093/jsxmed/qdag315.

    PubMed 42830722

Questions about this trial

What is this clinical trial studying?

An observational study of Female Sexual Function During Pregnancy and Pregnancy, run by Okan University at 1 site in Turkey (Türkiye).

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 5 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jul 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Female Sexual Function Index (FSFI) Total Score (time frame: Baseline (first trimester; 11-13 weeks' gestation), second trimester (20-24 weeks' gestation), and third trimester (32-36 weeks' gestation).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07403994, which also lists 1 linked publication.

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 13 Jul 2026.

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