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CompletedNCT05093647Updated May 11, 2022

Sexual Function Changes in High-Risk Pregnancies

An observational study in Sexual Dysfunctions, Psychological, High Risk Pregnancy and Sexual Behavior, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by Saglik Bilimleri Universitesi · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

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).

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Conditions studied

  • Sexual Dysfunctions, Psychological
  • High Risk Pregnancy
  • Sexual Behavior

Keywords

  • sexual dysfunction, high-risk pregnancy, FSFI, quality of life
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In context

Sexual Dysfunctions, Psychological

119 studies on the registry are indexed under Sexual Dysfunctions, Psychological; 9 are open to participants now.

This study's enrollment of 200 is below the median of 255 across 14 observational studies indexed under Sexual Dysfunctions, Psychological.

Browse Sexual Dysfunctions, Psychological studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 447 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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,

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Sexual dysfunction rate in high risk pregnancies

    Sexual dysfunction rate

    Time frame: 3 month

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Study locations

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, Turkey (Türkiye)
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References and documents

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 27871953 ↗
  • Alizadeh 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 33944668 ↗
  • Sartorao 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 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2021 to primary completion in Jul 2021, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2021
First posted
Oct 26, 2021
StartActual
Apr 15, 2021
Primary completionActual
Jul 30, 2021
CompletionActual
Jul 30, 2021
Last update
May 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05093647
Responsible party
Sevim Özge Özdemir (perinatology specialist, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Oct 26, 2021
Start date
Apr 15, 2021
Primary completion
Jul 30, 2021
Completion
Jul 30, 2021
Last update
May 11, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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