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

August 4, 2021 updated by: Sebnem Alanya Tosun, Giresun University
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Giresun, Turkey
        • Sebnem Alanya Tosun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Primiparous women 5-10 years after birth

Exclusion Criteria:

  • Multiparous women Women with connective tissue disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Nulliparous women
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

August 20, 2021

Study Completion (Anticipated)

September 20, 2021

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mode of Delivery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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