First Time Mothers and Anal Incontinence Six Years Postpartum
FiTMAI6
1 other identifier
observational
800
0 countries
N/A
Brief Summary
Previous studies show that incontinence is relatively common during pregnancy and after delivery. Experiencing incontinence during pregnancy or in the first year after delivery increases the risk of long term incontinence. There is scarce documentation of the long term prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and risk factors for incontinence approximately six years after delivery among the 1718 who participated in two previous studies exploring the prevalence and predictors of anal incontinence in late pregnancy and during the first year after first delivery, and the effect of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased awareness and knowledge about risk factors and long term prevalence of anal incontinence among health professionals as well as pregnant and parous women may give indications about which women to target for preventative measures to reduce the risk of new onset of postpartum AI during pregnancy and after delivery. Further, increased knowledge may aid in planning individualized follow-up during pregnancy and the first year as well as in the long term among women with existing AI symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Shorter than P25 for all trials
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
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedSeptember 25, 2017
September 1, 2017
11 months
June 2, 2016
September 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Anal incontinence
St. Mark's score measuring frequency and severity of anal incontinence
Anal incontinence six years postpartum
Secondary Outcomes (1)
Urinary incontinence
urinary incontinence six years postpartum
Eligibility Criteria
Parous women participating in two previous studies (1. primiparae delivering their first child between May 2009 and December2010 and 2. women with anal incontinence postpartum)
You may qualify if:
- Participants in previous studies
You may not qualify if:
- Women not participating in previous studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hege H Johannessen, PhD
Ostfold Hospital Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post Doctor
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 7, 2016
Study Start
August 1, 2016
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
September 25, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share