Pregnancy, Multiple Clinical Trial
— JUMODA-CPOfficial title:
Perineal Consequences of Twin Pregnancies According to Mode of Delivery
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | CHRU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | |
France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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 |
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