Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1641 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-02-28

Brief Summary

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The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse. There is a lack of studies that follow women several years after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this study is to get more knowledge about pathology of prolapse and incontinence, to enable development of preventive strategies for these conditions.

Aim of the study is to determine whether the prevalence of symptoms and performed surgery for urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery and cesarean section 15-20 years after their first delivery.

The investigators identify women that delivered their first child at St. Olavs Hospital, Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7, PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of prolapse performed.

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Detailed Description

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Conditions

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Uterine Prolapse Urinary Incontinence Fecal Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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vaginal birth

women whose first child was born by spontaneous vaginal delivery

vaginal delivery

Intervention Type PROCEDURE

cesarean section

women whose first child was born by cesarean section

cesarean section

Intervention Type PROCEDURE

forceps

women whose first child was born by forceps extraction

forceps extraction

Intervention Type PROCEDURE

vaginal delivery by forceps extraction

vacuum

women whose first child was born by vacuum extraction

vacuum extraction

Intervention Type PROCEDURE

vaginal delivery by vacuum extraction

Interventions

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vaginal delivery

Intervention Type PROCEDURE

forceps extraction

vaginal delivery by forceps extraction

Intervention Type PROCEDURE

vacuum extraction

vaginal delivery by vacuum extraction

Intervention Type PROCEDURE

cesarean section

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* first delivery in time period 1990-1997
* vaginal birth, spontaneous, forceps or vacuum extraction, or cesarean section
* residency in Klæbu, Malvik, Melhus, Midtre Gauldal, Rissa, Selbu, Trondheim, Tydal, Åfjord at the time of first delivery

Exclusion Criteria

* stillbirth
* breech birth
* congenital Abnormalities
* residency outside the 9 selected communities
* forceps delivery following previous vacuum extraction delivery or spontaneous vaginal birth
* vacuum extraction delivery following previous forceps delivery or spontaneous vaginal birth
* Vaginal birth following previous cesarean section

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No