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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Multiple
• Intervention / Treatment: Other: Questionnaires sent by mail

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 Type: Observational
• Enrollment (Actual): 3039

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
  • Nîmes, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is an ancillary to the "JUMODA" study (please see NCT01987063). The study population is composed of primiparous women pregnant with twins (non primiparous patients in the study JUMODA will therefore not includable), giving birth after 34 weeks to 2 live children.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaginal birth; Patients in the group give birth vaginally. Intervention: Questionnaires sent by mail	Other: Questionnaires sent by mail; The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.
Cesaren section; Patients in this group give birth via cesarean section. Intervention: Questionnaires sent by mail	Other: Questionnaires sent by mail; The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ICIQ-UI questionnaire	ICIQ-Urinary Incontinence Form	3 months post-partum
The PFDI-20 questionnaire		3 months post-partum
The ICIQ-UI questionnaire	ICIQ-Urinary Incontinence Form	12 months post-partum
The PFDI-20 questionnaire		12 months post-partum
The PFIQ-7 questionnaire		3 months post-partum
The PFIQ-7 questionnaire		12 months post-partum
The PISQ-12 questionnaire		3 months post-partum
The PISQ-12 questionnaire		12 months post-partum
The SF-12 questionnaire		3 months post-partum
The SF-12 questionnaire		12 months post-partum

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Renaud de Tayrac, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Bechard F, Castelli C, Alonso S, Vintejoux E, Goffinet F, Letouzey V, Schmitz T, de Tayrac R. Impact of mode of delivery of twins on the pelvic floor 3 and 12 months post-partum-part II. Int Urogynecol J. 2019 Jun;30(6):893-899. doi: 10.1007/s00192-018-3785-1. Epub 2018 Oct 5.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimated): February 11, 2014

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; cesarean section; twins; urinary incontinence; vaginal birth; sexuality
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Sexual Behavior; Urinary Incontinence; Sexuality
• Other Study ID Numbers: AOI/2013/RdeT; EGY/TDG/AR141876 (Other Identifier: CNIL)