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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal birth | Patients in the group give birth vaginally. Intervention: Questionnaires sent by mail |
| |
| Cesaren section | Patients in this group give birth via cesarean section. Intervention: Questionnaires sent by mail |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires sent by mail | Other | The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The ICIQ-UI questionnaire | ICIQ-Urinary Incontinence Form | 3 months post-partum |
| The PFDI-20 questionnaire | 3 months post-partum | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Renaud de Tayrac, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30291380 | Result | Bechard F, Castelli C, Alonso S, Vintejoux E, Goffinet F, Letouzey V, Schmitz T, de Tayrac R. Impact of mode of delivery of twins on the pelvic floor 3 and 12 months post-partum-part II. Int Urogynecol J. 2019 Jun;30(6):893-899. doi: 10.1007/s00192-018-3785-1. Epub 2018 Oct 5. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| Nîmes |
| 30029 |
| France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |