The Effect of the Mode of Delivery to the Pelvic Floor Fu... | NCT04474275

Studies
The Effect of the Mode of Delivery to the Pelvic Floor Function

NCT04474275

Sponsor

Giresun University

Status

Unknown status

Last Update Posted

Aug 6, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Incontinence
Pelvic Organ Prolapse

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Aug 20, 2021Estimated

Completion Date

Sep 20, 2021Estimated

First Submitted Date

Jun 18, 2020

First Submission Date that Met QC Criteria

Jul 13, 2020

First Posted Date

Jul 16, 2020Actual

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

Aug 4, 2021

Last Update Posted Date

Aug 6, 2021Actual

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

The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. The investigators wondered if the mode of deliveries such as ceserean section, vaginal route delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor function differently or not. In order to evaluate this, the investigators are planning to measure the muscle tonus in primiparous women.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group 1		Primiparous women who gave birth with ceserean section
Study group 2		Primiparous women who gave birth with vaginal route delivery without episiotomy
Study group 3		Primiparous women who gave birth with vaginal route delivery with episiotomy
Control group		Nulliparous women

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pelvic floor muscle tonus	Pelvic floor muscle tonus is going to measure by vaginal perineometry.	25.05.2020- 25.08.2020

Secondary Outcomes

Measure	Description	Time Frame
Female sexual function	Female sexual function is going to evaluate by validated FSFI questionnaire	25.05.2020- 25.08.2020

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primiparous women 5-10 years after birth

Exclusion Criteria:

Multiparous women Women with connective tissue disorders

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Only primiparous women

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

18-40 years old primiparous women who gave birth 5-10 years ago.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sebnem Alanya Tosun		Giresun			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided