Clinical trial NCT02059746: Perineal Consequences of Twin Pregnancies According to Mode of Delivery
Official title: Perineal Consequences of Twin Pregnancies According to Mode of Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy, Multiple
Keywords: cesarean section
vaginal birth
twins
urinary incontinence
sexuality
quality of life
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 3039
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility 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

Primary outcomes:
measure: Presence/absence of urinary incontinence
timeFrame: 3 months post-partum
Secondary outcomes:
measure: The ICIQ-UI questionnaire
timeFrame: 3 months post-partum
measure: The PFDI-20 questionnaire
timeFrame: 3 months post-partum
measure: The ICIQ-UI questionnaire
timeFrame: 12 months post-partum
measure: The PFDI-20 questionnaire
timeFrame: 12 months post-partum
measure: The PFIQ-7 questionnaire
timeFrame: 3 months post-partum
measure: The PFIQ-7 questionnaire
timeFrame: 12 months post-partum
measure: The PISQ-12 questionnaire
timeFrame: 3 months post-partum
measure: The PISQ-12 questionnaire
timeFrame: 12 months post-partum
measure: The SF-12 questionnaire
timeFrame: 3 months post-partum
measure: The SF-12 questionnaire
timeFrame: 12 months post-partum
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Renaud de Tayrac, MD, PhD
role: STUDY_DIRECTOR
References: