Sexual Function in High-risk Pregnant Women | NCT06130150

Studies
Sexual Function in High-risk Pregnant Women

NCT06130150

Sponsor

Karabuk University

Status

Unknown status

Last Update Posted

Nov 14, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

High Risk Pregnancy
Sexual Dysfunction
Anxiety
Female Sexual Function

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2021Actual

Primary Completion Date

Jan 10, 2022Actual

Completion Date

Jan 2024Estimated

First Submitted Date

Nov 8, 2023

First Submission Date that Met QC Criteria

Nov 8, 2023

First Posted Date

Nov 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2023

Last Update Posted Date

Nov 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-risk		This group includes pregnant women with the risk factors determined in the study
Normal		This group includes pregnant women with no risk

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1	High-risk pregnant women have lower FSFI score results then normal pregnant women	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: - Pregnant women over 18 years old, -Pregnant women 39 years old and under, -Pregnant women in their 3rd trimester.

Exclusion Criteria: - Pregnant women under 18 years old, -Pregnant women over 40 years old, -Pregnant women in their 1st or 2nd trimester.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant women between the ages of 18-40 who were diagnosed with risky pregnancy for any reason during their pregnancy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cagdas Nurettin Emeklioglu, MD	Contact	+905359129913		c.n.emeklioglu@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. Cemil Tascioglu City Hospital	Recruiting	Istanbul	Sisli	34384	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D012735	Sexual Dysfunction, Physiological
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided