Perineal Consequences of Twin Pregnancies According to Mode of Delivery (JUMODA-CP)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Pregnancy, Multiple

Treatments: Other: Questionnaires sent by mail

Study type: Observational

Funder types: Other

Identifiers

NCT02059746

AOI/2013/RdeT

EGY/TDG/AR141876 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,039 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,039 participants in 2 patient groups

Vaginal birth

Description:

Patients in the group give birth vaginally. Intervention: Questionnaires sent by mail

Treatment:

Other: Questionnaires sent by mail

Cesaren section

Description:

Patients in this group give birth via cesarean section. Intervention: Questionnaires sent by mail

Treatment:

Other: Questionnaires sent by mail