First Time Mothers and Anal Incontinence Six Years Postpartum

Quality of Life Clinical Trial

— FiTMAI6  

Official title:

First Time Mothers and Anal Incontinence Six Years Postpartum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792244
• Other study ID #: AB3299
• Status: Completed
• Phase: N/A
• First received: June 2, 2016
• Last updated: September 20, 2017
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants in previous studies

Exclusion Criteria:

• Women not participating in previous studies

Related Conditions & MeSH terms

• Enuresis
• Fecal Incontinence
• Quality of Life
• Urinary Incontinence

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Norwegian University of Science and Technology, St.Olavs Hospital, Trondheim University Hospital, Norway

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal incontinence	St. Mark's score measuring frequency and severity of anal incontinence	Anal incontinence six years postpartum
Secondary	Urinary incontinence	ICI-Q UI SF measuring frequency and severity of urinary incontinence	urinary incontinence six years postpartum