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

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ClinicalTrials.gov Identifier: NCT02059746
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.


Condition or disease Intervention/treatment
Pregnancy, Multiple 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
Actual Enrollment : 3039 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perineal Consequences of Twin Pregnancies According to Mode of Delivery
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059746


Locations
France
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Renaud de Tayrac, MD, PhD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02059746     History of Changes
Other Study ID Numbers: AOI/2013/RdeT
EGY/TDG/AR141876 ( Other Identifier: CNIL )
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
cesarean section
vaginal birth
twins
urinary incontinence
sexuality
quality of life