Perineal Consequences of Twin Pregnancies According to Mode of Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3039 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care

NCT01905644

Delivery, Obstetric

COMPLETED NA

Neonatal Outcomes in Twin Pregnancies

NCT05104255

Twin Pregnancy Neonate

COMPLETED

In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

NCT05556304

Perineum; Rupture Perineum; Tear Perineal Tear

UNKNOWN NA

The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins

NCT00187369

Twin Pregnancy

COMPLETED NA

Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.

NCT07124676

Vaginal Laceration During Delivery

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy, Multiple

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaginal birth

Patients in the group give birth vaginally.

Intervention: Questionnaires sent by mail

Questionnaires sent by mail

Intervention Type OTHER

The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.

Cesaren section

Patients in this group give birth via cesarean section.

Intervention: Questionnaires sent by mail

Questionnaires sent by mail

Intervention Type OTHER

The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaires sent by mail

The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No