Clincosm LogoSign in Get a demo

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

Sponsor
Giresun University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04474275
Collaborator
(none)
200
Enrollment
1
Location
15.6
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Effect of the Mode of Delivery to the Pelvic Floor Function
    Actual Study Start Date :
    Jun 1, 2020
    Anticipated Primary Completion Date :
    Aug 20, 2021
    Anticipated Study Completion Date :
    Sep 20, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Pelvic floor muscle tonus [25.05.2020- 25.08.2020]

      Pelvic floor muscle tonus is going to measure by vaginal perineometry.

    Secondary Outcome Measures

    1. Female sexual function [25.05.2020- 25.08.2020]

      Female sexual function is going to evaluate by validated FSFI questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Primiparous women 5-10 years after birth
    Exclusion Criteria:
    • Multiparous women Women with connective tissue disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sebnem Alanya Tosun Giresun Turkey

    Sponsors and Collaborators

    • Giresun University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sebnem Alanya Tosun, Assistant Professor, Giresun University
    ClinicalTrials.gov Identifier:
    NCT04474275
    Other Study ID Numbers:
    • Mode of Delivery
    First Posted:
    Jul 16, 2020
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sebnem Alanya Tosun, Assistant Professor, Giresun University
    pelvic organ prolapse
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Aug 6, 2021