NCT02059746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,039

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 19, 2025

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

February 7, 2014

Last Update Submit

November 17, 2025

Conditions

Pregnancy, Multiple

Keywords

cesarean sectionvaginal birthtwinsurinary incontinencesexualityquality of life

Outcome Measures

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.

    3 months post-partum

Secondary Outcomes (10)

  • The ICIQ-UI questionnaire

    3 months post-partum

  • The PFDI-20 questionnaire

    3 months post-partum

  • The ICIQ-UI questionnaire

    12 months post-partum

  • The PFDI-20 questionnaire

    12 months post-partum

  • The PFIQ-7 questionnaire

    3 months post-partum

  • +5 more secondary outcomes

Study Arms (2)

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

Questionnaires sent by mailOTHER

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

Cesaren sectionVaginal birth

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 30291380RESULT

MeSH Terms

Conditions

Urinary IncontinenceSexuality

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Study Officials

  • Renaud de Tayrac, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 11, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

November 19, 2025

Record last verified: 2016-04

Locations

FR(2)