Perineal Consequences of Twin Pregnancies According to Mode of Delivery

Completed

• Conditions: Pregnancy, Multiple
• Interventions: Other: Questionnaires sent by mail

• Registration Number: NCT02059746
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

This is an ancillary study to the "JUMODA" (National Prospective and Comparative Study on the Mode of Delivery of Twins) study: please see NCT01987063.

The main objective of this study is to investigate the role of the mode of delivery (vaginal versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.

Detailed Description

The secondary objectives of this study are to compare the following elements between primiparous mothers giving birth to twins vaginally versus by caesarean section after 34 weeks of pregnancy (comparisons will be made at 3 months ant at 12 months post-partum):

A. Diagnosis, type and severity of urinary incontinence via the ICIQ-UI questionnaire

B. Urinary, anorectal and perineal symptoms via the PFDI-20 questionnaire

C. Quality of life related to urinary, anorectal and pelvic floor symptoms via the PFIQ-7 questionnaire

D. Sexuality via the PISQ-12 questionnaire

E. General quality of life via the SF-12 questionnaire

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-11
• Primary Completion: 2015-06
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3039

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 12 months of follow-up following delivery
• The patient was included in the JUMODA study
• Primiparous
• Birth of 2 live children after 34 weeks of pregnancy

Exclusion Criteria

• Adult patient under guardianship
• Patient under judicial protection
• It proves impossible to correctly inform the patient
• Birth occurring before 34 weeks of pregnancy
• Birth not resulting in 2 living children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaginal birth	Questionnaires sent by mail	Patients in the group give birth vaginally. Intervention: Questionnaires sent by mail
Cesaren section	Questionnaires sent by mail	Patients in this group give birth via cesarean section. Intervention: Questionnaires sent by mail

Primary Outcome Measures

Name	Time	Method
Presence/absence of urinary incontinence	3 months post-partum	Defined by a response of 1 to 5 on the first question of the ICIQ-UI questionnaire.

Secondary Outcome Measures

Name	Time	Method
The PFDI-20 questionnaire	12 months post-partum
The PISQ-12 questionnaire	12 months post-partum
The PFIQ-7 questionnaire	12 months post-partum
The SF-12 questionnaire	12 months post-partum
The ICIQ-UI questionnaire	12 months post-partum	ICIQ-Urinary Incontinence Form

Trial Locations

Locations (2)

CHRU de Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France