NCT05093647

Brief Summary

Sexual Function Changes in High-Risk Pregnancies

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

October 3, 2021

Last Update Submit

May 5, 2022

Conditions

Sexual Dysfunctions, PsychologicalHigh Risk PregnancySexual Behavior

Keywords

sexual dysfunction, high-risk pregnancy, FSFI, quality of life

Outcome Measures

Primary Outcomes (1)

  • Sexual dysfunction rate in high risk pregnancies

    Sexual dysfunction rate

    3 month

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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)

Location

Related Publications (3)

  • 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.

    PMID: 27871953RESULT

  • 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.

    PMID: 33944668RESULT

  • 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.

    PMID: 32857893RESULT

MeSH Terms

Conditions

Sexual Dysfunctions, PsychologicalSexual BehaviorSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Mental DisordersBehaviorGenital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
perinatology specialist

Study Record Dates

First Submitted

October 3, 2021

First Posted

October 26, 2021

Study Start

April 15, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

TU(1)