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).
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
- Conditions the study is for
- Female Sexual Function During Pregnancy, Pregnancy, Female Sexual Function
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted11 Feb 2026
- Study start1 Sep 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Sexual Function During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçenur Karakelleoğlu, Okan University
- Investigators
- Gökçenur Karakelleoğlu, Principal investigator, Istanbul Okan University Hospital, Department of Obstetrics and Gynecology
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Longitudinal Impact of Prenatal Pilates on Female Sexual Function and Sexual Distress During Pregnancy
- ClinicalTrials.gov ID
- NCT07403994
- Acronym / sponsor ID
- PP-SEX / OKAN-PP-FSFI-2025
- Keywords
- Pregnancy, Prenatal Pilates, Female Sexual Function, Sexual Distress, FSFI, FSDS-R, Physical Activity, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
1 secondary outcome
Female Sexual Distress Scale-Revised (FSDS-R) Total Score
Time frame: Baseline (first trimester; 11-13 weeks' gestation), second trimester (20-24 weeks' gestation), and third trimester (32-36 weeks' gestation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 42830722Karakelleoglu 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy concerns and the sensitive nature of questionnaire-based sexual health information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökçenur Karakelleoğlu principal investigator
Istanbul Okan University Hospital, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
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.