NCT03117504

Brief Summary

Stress urinary incontinence is the most common type of incontinence during pregnancy.our study aims at determining the prevalence in the first and third trimesters and the associated risk factors.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
suspended

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

January 5, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

March 21, 2017

Last Update Submit

April 17, 2017

Conditions

Keywords

Stress urinary incontinenceSUI

Outcome Measures

Primary Outcomes (1)

  • Prevalence of stress urinary incontinence during first trimester pregnancy

    Determine the prevalence and associated risk factors in the first trimester

    2 years

Secondary Outcomes (1)

  • Prevalence of stress urinary incontinence during third trimester pregnancy

    2 years

Study Arms (2)

First trimester

women during first trimester(less than 14 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.

Other: questionnaire

Third trimester

women during third trimester(more than 28 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.

Other: questionnaire

Interventions

a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.

First trimesterThird trimester

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cross-sectional study of two groups of women will be conducted. Each group consists of 250 patients with a total number of 500 patients * group 1 : women during first trimester(less than 14 weeks of pregnancy). * group 2: women during third trimester (more than 28 weeks of pregnancy).

You may qualify if:

  • Pregnant women in first and third trimesters

You may not qualify if:

  • Communication problems.
  • Mental disturbances.
  • Previous surgery for incontinence or other pelvic procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Faculty of Medicine

Cairo Governorate, Cairo Governorate, 1156, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hazem M Sammour, MD

    Ain Shams Maternity Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of obstetrics&gynecology

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 18, 2017

Study Start

January 5, 2016

Primary Completion

May 20, 2017

Study Completion

July 20, 2017

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations