Perineal Consequences of Twin Pregnancies According to Mode of Delivery

Study Overview
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Brief Summary
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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
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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

Official Title
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Perineal Consequences of Twin Pregnancies According to Mode of Delivery

Conditions
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Pregnancy, Multiple

Intervention / Treatment
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* Other: Questionnaires sent by mail


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaginal birth<br>Patients in the group give birth vaginally. Intervention: Questionnaires sent by mail | Other: Questionnaires sent by mail<br>* The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.<br>|
| Cesaren section<br>Patients in this group give birth via cesarean section. Intervention: Questionnaires sent by mail | Other: Questionnaires sent by mail<br>* The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ICIQ-UI questionnaire | ICIQ-Urinary Incontinence Form | 3 months post-partum | 
| The PFDI-20 questionnaire |  | 3 months post-partum | 
| The ICIQ-UI questionnaire | ICIQ-Urinary Incontinence Form | 12 months post-partum | 
| The PFDI-20 questionnaire |  | 12 months post-partum | 
| The PFIQ-7 questionnaire |  | 3 months post-partum | 
| The PFIQ-7 questionnaire |  | 12 months post-partum | 
| The PISQ-12 questionnaire |  | 3 months post-partum | 
| The PISQ-12 questionnaire |  | 12 months post-partum | 
| The SF-12 questionnaire |  | 3 months post-partum | 
| The SF-12 questionnaire |  | 12 months post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, vaginal birth, twins, urinary incontinence, sexuality, quality of life