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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05093647
Other study ID # FSFI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date July 30, 2021

Study information

Verified date May 2022
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Sexual Function Changes in High-Risk Pregnancies


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).


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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, -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Basaksehir City Hospital, Hamidiye School of Medicine, University of Health Sciences, Basaksehir Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. 2021 May 4:1-9. doi: 10.10 — View 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.sxm — View Citation

Sartorão 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 duri — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sexual dysfunction rate in high risk pregnancies Sexual dysfunction rate 3 month
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