NCT03126604

Brief Summary

A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

April 20, 2017

Last Update Submit

April 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • urinary incontinence

    evaluation using the International Consultation on Incontinence Questionnaire Short Form

    6 months after delivery

Study Arms (2)

vaginal delivery

Women underwent non complicated non instumental normal vaginal delivery

Diagnostic Test: female sexual function index

Cesarean section

Women underwent elective Cesarean section

Diagnostic Test: female sexual function index

Interventions

evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions

Cesarean sectionvaginal delivery

Eligibility Criteria

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

women who delivered vaginally or Cesarean for the first time within 6 months to 5 years before evaluation

You may qualify if:

  • primiparity,
  • singleton pregnancy
  • cephalic presentation
  • term delivery (38-42 weeks).

You may not qualify if:

  • Women with operative vaginal delivery (vacuum extraction or forceps delivery)
  • women who had another delivery between the time of first one and time of evaluation
  • women with neurological diseases
  • women with vascular diseases and Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 24, 2017

Study Start

May 1, 2017

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

April 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations