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CompletedNCT02059746JUMODA-CPUpdated Nov 19, 2025

Perineal Consequences of Twin Pregnancies According to Mode of Delivery

An observational study in Pregnancy, Multiple, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,039
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Pregnancy, Multiple

Keywords

  • cesarean section
  • vaginal birth
  • twins
  • urinary incontinence
  • sexuality
  • quality of life
03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's enrollment of 3,039 is above the median of 120 across 215 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,039 participants (actual)
Patient registry
No

Groups and cohorts

  • Vaginal birth

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

    Other: Questionnaires sent by mail

  • Cesaren section

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

    Other: Questionnaires sent by mail

Interventions

  • OtherQuestionnaires sent by mail

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

06

What researchers measure

Primary outcomes

  1. 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

  1. The ICIQ-UI questionnaire

    ICIQ-Urinary Incontinence Form

    Time frame: 3 months post-partum

  2. The PFDI-20 questionnaire

    Time frame: 3 months post-partum

  3. The ICIQ-UI questionnaire

    ICIQ-Urinary Incontinence Form

    Time frame: 12 months post-partum

  4. The PFDI-20 questionnaire

    Time frame: 12 months post-partum

  5. The PFIQ-7 questionnaire

    Time frame: 3 months post-partum

  6. The PFIQ-7 questionnaire

    Time frame: 12 months post-partum

  7. The PISQ-12 questionnaire

    Time frame: 3 months post-partum

  8. The PISQ-12 questionnaire

    Time frame: 12 months post-partum

  9. The SF-12 questionnaire

    Time frame: 3 months post-partum

  10. The SF-12 questionnaire

    Time frame: 12 months post-partum

07

Study locations

2 sites
  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
    Montpellier, 34295, France
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes, 30029, France
08

References and documents

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. PubMed 30291380 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02059746
Responsible party
Sponsor
First posted
Feb 11, 2014
Start date
Feb 2014
Primary completion
Mar 1, 2015
Completion
Mar 1, 2016
Last update
Nov 19, 2025

Study contacts

Renaud de Tayrac, MD, PhD
study director · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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