Perineal Consequences of Twin Pregnancies According to Mode of Delivery

N/ACompletedNCT02059746

Centre Hospitalier Universitaire de Nīmes3,039 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

3,039

Conditions

Pregnancy, Multiple

Interventions

Questionnaires sent by mailOTHER

The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Presence/absence of urinary incontinence

Defined by a response of 1 to 5 on the first question of the ICIQ-UI questionnaire.

Time frame: 3 months post-partum

Secondary Outcomes

The ICIQ-UI questionnaire

ICIQ-Urinary Incontinence Form

Time frame: 3 months post-partum

The PFDI-20 questionnaire

Time frame: 3 months post-partum

The ICIQ-UI questionnaire

ICIQ-Urinary Incontinence Form

Time frame: 12 months post-partum

The PFDI-20 questionnaire

Time frame: 12 months post-partum

The PFIQ-7 questionnaire

Time frame: 3 months post-partum

The PFIQ-7 questionnaire

Time frame: 12 months post-partum

The PISQ-12 questionnaire

Time frame: 3 months post-partum

The PISQ-12 questionnaire

Time frame: 12 months post-partum

The SF-12 questionnaire

Time frame: 3 months post-partum

The SF-12 questionnaire

Time frame: 12 months post-partum

Data from ClinicalTrials.gov

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