Sexual Dysfunctions, PsychologicalNCT05093647
Sexual Function Changes in High-Risk Pregnancies
An observational study of Sexual Dysfunctions, Psychological and High Risk Pregnancy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Sexual Function Changes in High-Risk Pregnancies Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunctions, Psychological, High Risk Pregnancy, Sexual Behavior
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 30 Jul 2021
- How long will I take part?
- 3 Months
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The women who followed up for HrP were invited to participate and women with HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, and followed up at our perinatology department with a diagnosis of IUGR, cholestasis, diabetes, preeclampsia, or hypertension were included.
Who may be able to join
- study grup Pregnant women who ; followed up for HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, followed up at our perinatology department with a diagnosis of IUGR, cholestasis, diabetes, preeclampsia, fetal anomaly control grup admitted for routine second-trimester ultrasonography assessment but with no risk for pregnancy
Who cannot join
- Pregnant women who ; younger than 20 or older than 40 years of age, gestation in the 1st or 3rd trimester, presence of psychiatric or chronic disorders like rheumatic or heart diseases,
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Başakşehir City Hospital, Hamidiye School of Medicine, University of Health Sciences,
Başaksehir, Istanbul, 34480
About this study
Sexual Function Changes in High-Risk Pregnancies
Read the detailed description
Background and Aim: Sexual functions generally decrease during pregnancy, and high-risk pregnancies are more severe clinical conditions that cause couples to reduce or abstain entirely from their intimacy. However, the evidence on the sexual functions in high-risk pregnancies is scarce. Therefore, this study aimed to evaluate the sexual function changes in high-risk pregnancies compared to normal pregnancies.
Methods: A total of 200 pregnant women (100 women in high-risk pregnancy and normal pregnancy groups each) were included. Demographic and obstetric data were collected, and participants completed The Female Sexual Function Index (FSFI).
- Keywords
- sexual dysfunction, high-risk pregnancy, FSFI, quality of life
- Medical subject headings
- Sexual Dysfunctions, Psychological, Sexual Behavior, Sexual Dysfunction, Physiological
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 |
|---|---|---|
| patient | The women who followed up for HrP (high-risk pregnancy ) were invited to participate and women with HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, and followed up at our perinatology department with a diagnosis of IUGR (intrauterine growth retardation ), cholestasis, diabetes, preeclampsia, or hypertension were included. | |
| control | The pregnant women admitted for routine second-trimester ultrasonography assessment but with no risk for pregnancy formed the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual dysfunction rate in high risk pregnancies
Sexual dysfunction rate
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start15 Apr 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual Dysfunctions, PsychologicalStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Özge Özdemir, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093647
- Sponsor's protocol ID
- FSFI
- Status last verified
- May 2022
- First submitted
- 3 Oct 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McCool ME, Zuelke A, Theurich MA, Knuettel H, Ricci C, Apfelbacher C. Prevalence of Female Sexual Dysfunction Among Premenopausal Women: A Systematic Review and Meta-Analysis of Observational Studies. Sex Med Rev. 2016 Jul;4(3):197-212. doi: 10.1016/j.sxmr.2016.03.002. Epub 2016 Apr 19.
PubMed 27871953Alizadeh S, Riazi H, Alavi-Majd H, Ozgoli G. Prevalence of female sexual dysfunction during pregnancy in Eastern Mediterranean Regional Office Countries (EMRO): a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6654-6662. doi: 10.1080/14767058.2021.1919074. Epub 2021 May 4.
PubMed 33944668Sartorao Filho CI, Pinheiro FA, Prudencio CB, Nunes SK, Takano L, Enriquez EMA, Orlandi MIG, Junginger B, Hallur RLS, Rudge MVC, Barbosa AMP. Impact of gestational diabetes on pelvic floor: A prospective cohort study with three-dimensional ultrasound during two-time points in pregnancy. Neurourol Urodyn. 2020 Nov;39(8):2329-2337. doi: 10.1002/nau.24491. Epub 2020 Aug 28.
PubMed 32857893
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function Changes in High-Risk Pregnancies
- ClinicalTrials.gov ID
- NCT05093647
- Acronym / sponsor ID
- FSFI
- Keywords
- sexual dysfunction, high-risk pregnancy, FSFI, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 26 Oct 2021 (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.
Sexual Function Changes in High-Risk Pregnancies
Detailed description
Background and Aim: Sexual functions generally decrease during pregnancy, and high-risk pregnancies are more severe clinical conditions that cause couples to reduce or abstain entirely from their intimacy. However, the evidence on the sexual functions in high-risk pregnancies is scarce. Therefore, this study aimed to evaluate the sexual function changes in high-risk pregnancies compared to normal pregnancies.
Methods: A total of 200 pregnant women (100 women in high-risk pregnancy and normal pregnancy groups each) were included. Demographic and obstetric data were collected, and participants completed The Female Sexual Function Index (FSFI).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | –The women who followed up for HrP (high-risk pregnancy ) were invited to participate and women with HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, and followed up at our perinatology department with a diagnosis of IUGR (intrauterine growth retardation ), cholestasis, diabetes, preeclampsia, or hypertension were included. |
| control | – | –The pregnant women admitted for routine second-trimester ultrasonography assessment but with no risk for pregnancy formed the control group. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The women who followed up for HrP were invited to participate and women with HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, and followed up at our perinatology department with a diagnosis of IUGR, cholestasis, diabetes, preeclampsia, or hypertension were included.
Key inclusion criteria (1 listed)
- study grup Pregnant women who ; followed up for HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, followed up at our perinatology department with a diagnosis of IUGR, cholestasis, diabetes, preeclampsia, fetal anomaly control grup admitted for routine second-trimester ultrasonography assessment but with no risk for pregnancy
Key exclusion criteria (2 listed)
- Pregnant women who ; younger than 20 or older than 40 years of age, gestation in the 1st or 3rd trimester, presence of psychiatric or chronic disorders like rheumatic or heart diseases,
- -
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
Sexual dysfunction rate in high risk pregnancies
Time frame: 3 month
Sexual dysfunction rate
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 11 May 2022.
- Results publication: PubMed 27871953McCool ME, Zuelke A, Theurich MA, Knuettel H, Ricci C, Apfelbacher C. Prevalence of Female Sexual Dysfunction Among Premenopausal Women: A Systematic Review and Meta-Analysis of Observational Studies. Sex Med Rev. 2016 Jul;4(3):197-212. doi: 10.1016/j.sxmr.2016.03.002. Epub 2016 Apr 19.
- Results publication: PubMed 33944668Alizadeh S, Riazi H, Alavi-Majd H, Ozgoli G. Prevalence of female sexual dysfunction during pregnancy in Eastern Mediterranean Regional Office Countries (EMRO): a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6654-6662. doi: 10.1080/14767058.2021.1919074. Epub 2021 May 4.
- Results publication: PubMed 32857893Sartorao Filho CI, Pinheiro FA, Prudencio CB, Nunes SK, Takano L, Enriquez EMA, Orlandi MIG, Junginger B, Hallur RLS, Rudge MVC, Barbosa AMP. Impact of gestational diabetes on pelvic floor: A prospective cohort study with three-dimensional ultrasound during two-time points in pregnancy. Neurourol Urodyn. 2020 Nov;39(8):2329-2337. doi: 10.1002/nau.24491. Epub 2020 Aug 28.
- Individual participant dataSharing planned: Undecided
Related trials for Sexual Dysfunctions, Psychological
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
Not yet recruiting
AI-Powered Sleep Hygiene Mentor for Adults Living With HIV
Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingObservational study
Comparative Study of Gender Identity Disorder Versus Control
Gender Dysphoria, Adult
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sexual Dysfunctions, Psychological and High Risk Pregnancy, run by Saglik Bilimleri Universitesi 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 1 inclusion and 2 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 11 May 2022. 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?
Sexual dysfunction rate in high risk pregnancies (time frame: 3 month). 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 NCT05093647, which also lists 3 linked publications.
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 11 May 2022.