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

Norwegian University of Science and Technology

Status: Completed

Conditions: Uterine Prolapse; Fecal Incontinence; Urinary Incontinence

Treatments: Procedure: cesarean section; Procedure: forceps extraction; Procedure: vacuum extraction; Procedure: vaginal delivery

Study type: Observational

Funder types: Other

Identifiers

NCT01766193

2012/666

Details and patient eligibility

About

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.

Enrollment: 1,641 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,641 participants in 4 patient groups

vaginal birth

Description:

women whose first child was born by spontaneous vaginal delivery

Treatment:

Procedure: vaginal delivery

cesarean section

Description:

women whose first child was born by cesarean section

Treatment:

Procedure: cesarean section

forceps

Description:

women whose first child was born by forceps extraction

Treatment:

Procedure: forceps extraction

vacuum

Description:

women whose first child was born by vacuum extraction

Treatment:

Procedure: vacuum extraction