Perineal Consequences of Twin Pregnancies According to Mode of Delivery

Pregnancy, Multiple Clinical Trial

— JUMODA-CP  

Official title:

Perineal Consequences of Twin Pregnancies According to Mode of Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059746
• Other study ID #: AOI/2013/RdeT
• Secondary ID: EGY/TDG/AR141876
• Status: Completed
• Phase: N/A
• First received: February 7, 2014
• Last updated: April 5, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3039
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy, Multiple

Intervention

Other:
• Questionnaires sent by mail
The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The ICIQ-UI questionnaire	ICIQ-Urinary Incontinence Form	3 months post-partum	No
Secondary	The PFDI-20 questionnaire		3 months post-partum	No
Secondary	The ICIQ-UI questionnaire	ICIQ-Urinary Incontinence Form	12 months post-partum	No
Secondary	The PFDI-20 questionnaire		12 months post-partum	No
Secondary	The PFIQ-7 questionnaire		3 months post-partum	No
Secondary	The PFIQ-7 questionnaire		12 months post-partum	No
Secondary	The PISQ-12 questionnaire		3 months post-partum	No
Secondary	The PISQ-12 questionnaire		12 months post-partum	No
Secondary	The SF-12 questionnaire		3 months post-partum	No
Secondary	The SF-12 questionnaire		12 months post-partum	No