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NCT04474275 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

Official title:
The Effect of the Mode of Delivery to the Pelvic Floor Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04474275
Other study ID # Mode of Delivery
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date September 20, 2021

Study information
Verified date August 2021
Source Giresun University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date September 20, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Primiparous women 5-10 years after birth Exclusion Criteria: - Multiparous women Women with connective tissue disorders

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Sebnem Alanya Tosun Giresun

Sponsors (1)
Lead Sponsor Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pelvic floor muscle tonus Pelvic floor muscle tonus is going to measure by vaginal perineometry. 25.05.2020- 25.08.2020
Secondary Female sexual function Female sexual function is going to evaluate by validated FSFI questionnaire 25.05.2020- 25.08.2020
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