Clinical trial NCT05093647: Sexual Function Changes in High-Risk Pregnancies
Official title: Sexual Function Changes in High-Risk Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunctions, Psychological
High Risk Pregnancy
Sexual Behavior
Keywords: sexual dysfunction, high-risk pregnancy, FSFI, quality of life
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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).

Eligibility criteria: 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:

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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Primary outcomes:
measure: Sexual dysfunction rate in high risk pregnancies
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Başaksehir
country: Turkey
facility: Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Başakşehir City Hospital, Hamidiye School of Medicine, University of Health Sciences,
state: İstanbul
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.