Pregnancy, Multiple
Conditions
Keywords
cesarean section, vaginal birth, twins, urinary incontinence, sexuality, quality of life
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
Interventions
OTHERQuestionnaires sent by mail
The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of urinary incontinence | 3 months post-partum | Defined by a response of 1 to 5 on the first question of the ICIQ-UI questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The PFDI-20 questionnaire | 3 months post-partum | — |
| The ICIQ-UI questionnaire | 3 months post-partum | ICIQ-Urinary Incontinence Form |
| The PFIQ-7 questionnaire | 3 months post-partum | — |
| The PISQ-12 questionnaire | 3 months post-partum | — |
| The SF-12 questionnaire | 3 months post-partum | — |
Countries
France
Outcome results
None listed