NCT04474275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

June 18, 2020

Last Update Submit

August 4, 2021

Conditions

IncontinencePelvic Organ Prolapse

Keywords

pelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

  • Pelvic floor muscle tonus

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

    25.05.2020- 25.08.2020

Secondary Outcomes (1)

  • Female sexual function

    25.05.2020- 25.08.2020

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly primiparous women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Primiparous women 5-10 years after birth

You may not qualify if:

  • Multiparous women Women with connective tissue disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sebnem Alanya Tosun

Giresun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2020

First Posted

July 16, 2020

Study Start

June 1, 2020

Primary Completion

August 20, 2021

Study Completion

September 20, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

TU(1)