Pregnancy, MultipleJUMODA-CPNCT02059746
Perineal Consequences of Twin Pregnancies According to Mode of Delivery
An observational study of Pregnancy, Multiple, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Multiple
- What is being tested?
- Questionnaires sent by mail
- How many people
- 3,039 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2014to 1 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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.
Read the 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):
- Diagnosis, type and severity of urinary incontinence via the ICIQ-UI questionnaire
- Urinary, anorectal and perineal symptoms via the PFDI-20 questionnaire
- Quality of life related to urinary, anorectal and pelvic floor symptoms via the PFIQ-7 questionnaire
- Sexuality via the PISQ-12 questionnaire
- General quality of life via the SF-12 questionnaire
- Conditions
- Pregnancy, Multiple
- Being tested
- Questionnaires sent by mail
- Keywords
- cesarean section, vaginal birth, twins, urinary incontinence, sexuality, quality of life
- Medical subject headings
- Urinary Incontinence, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires sent by mailOther
The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal birth | Patients in the group give birth vaginally.
Intervention: Questionnaires sent by mail Receives: Other: Questionnaires sent by mail | |
| Cesaren section | Patients in this group give birth via cesarean section.
Intervention: Questionnaires sent by mail Receives: Other: Questionnaires sent by mail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of urinary incontinence
Defined by a response of 1 to 5 on the first question of the ICIQ-UI questionnaire.
Measured: 3 months post-partum
Secondary outcomes (10)
The ICIQ-UI questionnaire
ICIQ-Urinary Incontinence Form
Measured: 3 months post-partum
The PFDI-20 questionnaire
Measured: 3 months post-partum
The ICIQ-UI questionnaire
ICIQ-Urinary Incontinence Form
Measured: 12 months post-partum
The PFDI-20 questionnaire
Measured: 12 months post-partum
The PFIQ-7 questionnaire
Measured: 3 months post-partum
The PFIQ-7 questionnaire
Measured: 12 months post-partum
The PISQ-12 questionnaire
Measured: 3 months post-partum
The PISQ-12 questionnaire
Measured: 12 months post-partum
The SF-12 questionnaire
Measured: 3 months post-partum
The SF-12 questionnaire
Measured: 12 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion1 Mar 2015
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, MultipleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,039 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud de Tayrac, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059746
- Sponsor's protocol ID
- AOI/2013/RdeT
- Acronym
- JUMODA-CP
- Status last verified
- Apr 2016
- First submitted
- 7 Feb 2014
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30291380
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Consequences of Twin Pregnancies According to Mode of Delivery
- ClinicalTrials.gov ID
- NCT02059746
- Acronym / sponsor ID
- JUMODA-CP / AOI/2013/RdeT
- Conditions
- Pregnancy, Multiple
- Keywords
- cesarean section, vaginal birth, twins, urinary incontinence, sexuality, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,039 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Diagnosis, type and severity of urinary incontinence via the ICIQ-UI questionnaire
- Urinary, anorectal and perineal symptoms via the PFDI-20 questionnaire
- Quality of life related to urinary, anorectal and pelvic floor symptoms via the PFIQ-7 questionnaire
- Sexuality via the PISQ-12 questionnaire
- General quality of life via the SF-12 questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal birth | – | Other: Questionnaires sent by mailPatients in the group give birth vaginally. Intervention: Questionnaires sent by mail |
| Cesaren section | – | Other: Questionnaires sent by mailPatients in this group give birth via cesarean section. Intervention: Questionnaires sent by mail |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires sent by mailThe questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum. | Other | Cesaren section, Vaginal birth |
Primary outcome
Presence/absence of urinary incontinence
Time frame: 3 months post-partum
Defined by a response of 1 to 5 on the first question of the ICIQ-UI questionnaire.
10 secondary outcomes
The ICIQ-UI questionnaire
Time frame: 3 months post-partum
The PFDI-20 questionnaire
Time frame: 3 months post-partum
The ICIQ-UI questionnaire
Time frame: 12 months post-partum
The PFDI-20 questionnaire
Time frame: 12 months post-partum
The PFIQ-7 questionnaire
Time frame: 3 months post-partum
The PFIQ-7 questionnaire
Time frame: 12 months post-partum
The PISQ-12 questionnaire
Time frame: 3 months post-partum
The PISQ-12 questionnaire
Time frame: 12 months post-partum
The SF-12 questionnaire
Time frame: 3 months post-partum
The SF-12 questionnaire
Time frame: 12 months post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 30291380Bechard 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud de Tayrac, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Multiple, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of urinary incontinence (time frame: 3 months post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.