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Completed

NCT Number: NCT02059746

Perineal Consequences of Twin Pregnancies According to Mode of Delivery

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.

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Key information

Conditions

Pregnancy, Multiple Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Sexual Behavior Sexuality Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires sent by mail

Other

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

Primary outcomes

  1. Presence/absence of urinary incontinence

    Time frame: 3 months post-partum

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

Secondary outcomes

  1. The ICIQ-UI questionnaire

    Time frame: 3 months post-partum

    ICIQ-Urinary Incontinence Form

  2. The PFDI-20 questionnaire

    Time frame: 3 months post-partum

  3. The ICIQ-UI questionnaire

    Time frame: 12 months post-partum

    ICIQ-Urinary Incontinence Form

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: JUMODA-CP

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 11, 2014
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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