Twin PregnancyNCT04232436
Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins
An observational study of Twin Pregnancy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The incidence of twin pregnancies has increased and currently accounts for 1.8% of all deliveries. 47.5% of twins are born prematurely (vs. 6% for singletons) of which 9.9% before 32SA. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Twin Pregnancy
- What is being tested?
- Survival at discharge and Survival without severe morbidity
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 1 Mar 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Twins born at Montpellier University Hospital between 24SA and 32SA+6
Who may be able to join
- twins born at Montpellier University Hospital
- between 24SA and 32SA+6
- January 2010 to July 2019
- The mothers must have gone into labour spontaneously or after preterm rupture of membranes
- first twin in cephalic presentation
Who cannot join
- twin to twin transfusion syndrome
- monoamniotic pregnancies
- cause of delivery other than preterm labor or preterm rupture of membranes
- lethal malformation
- first twin in breech or transverse presentation
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of twin pregnancies has increased and currently accounts for 1.8% of all deliveries. 47.5% of twins are born prematurely (vs. 6% for singletons) of which 9.9% before 32SA. Caesarean section rates are also higher than for singletons (53.7% vs 19.2%) and 31.8% of caesarean sections are performed before delivery.
The optimal mode of delivery for preterm twins remains controversial. The latest recommendations for clinical practice emphasize that it is not appropriate to recommend one mode of delivery rather than another in the case of twin pregnancies at any term.
In view of all these elements, we wished to carry out a retrospective study at the Montpellier University Hospital in order to compare the neonatal outcome of preterms twins according to their mode of delivery : planned vaginal delivery versus planned cesarean delivery.
- Conditions
- Twin Pregnancy
- Being tested
- Survival at discharge, Survival without severe morbidity
- Keywords
- Mode of delivery, Prematurity, Survival at discharge, Survival without severe morbidity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survival at dischargeOther
Survival at discharge
Survival without severe morbidityOther
Survival without severe morbidity (IVH, severe BPD, NEC, ROP)
| Study group | Role | What they receive |
|---|---|---|
| Planned vaginal delivery | Planned vaginal delivery Receives: Other: Survival at discharge; Other: Survival without severe morbidity | |
| Planned cesarean delivery | Planned cesarean delivery Receives: Other: Survival at discharge; Other: Survival without severe morbidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival at discharge and survival
survival at discharge and survival without severe morbidity
Measured: during neonatal hospitalization
Secondary outcomes (2)
survival at 2 years of corrected
survival at 2 years of corrected
Measured: during the first two years corrected age
age without neurosensory impairment
age without neurosensory impairment
Measured: during the first two years corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jul 2019
- Primary completion30 Jul 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232436
- Sponsor's protocol ID
- RECHMPL20_0035
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins
- ClinicalTrials.gov ID
- NCT04232436
- Acronym / sponsor ID
- RECHMPL20_0035
- Conditions
- Twin Pregnancy
- Keywords
- Mode of delivery, Prematurity, Survival at discharge, Survival without severe morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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.
The incidence of twin pregnancies has increased and currently accounts for 1.8% of all deliveries. 47.5% of twins are born prematurely (vs. 6% for singletons) of which 9.9% before 32SA. Caesarean section rates are also higher than for singletons (53.7% vs 19.2%) and 31.8% of caesarean sections are performed before delivery.
The optimal mode of delivery for preterm twins remains controversial. The latest recommendations for clinical practice emphasize that it is not appropriate to recommend one mode of delivery rather than another in the case of twin pregnancies at any term.
In view of all these elements, we wished to carry out a retrospective study at the Montpellier University Hospital in order to compare the neonatal outcome of preterms twins according to their mode of delivery : planned vaginal delivery versus planned cesarean delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned vaginal delivery | – | Other: Survival at discharge, Other: Survival without severe morbidityPlanned vaginal delivery |
| Planned cesarean delivery | – | Other: Survival at discharge, Other: Survival without severe morbidityPlanned cesarean delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twins born at Montpellier University Hospital between 24SA and 32SA+6
Key inclusion criteria (5 listed)
- twins born at Montpellier University Hospital
- between 24SA and 32SA+6
- January 2010 to July 2019
- The mothers must have gone into labour spontaneously or after preterm rupture of membranes
- first twin in cephalic presentation
Key exclusion criteria (5 listed)
- twin to twin transfusion syndrome
- monoamniotic pregnancies
- cause of delivery other than preterm labor or preterm rupture of membranes
- lethal malformation
- first twin in breech or transverse presentation
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 |
|---|---|---|
| Survival at dischargeSurvival at discharge | Other | Planned cesarean delivery, Planned vaginal delivery |
| Survival without severe morbiditySurvival without severe morbidity (IVH, severe BPD, NEC, ROP) | Other | Planned cesarean delivery, Planned vaginal delivery |
Primary outcome
survival at discharge and survival
Time frame: during neonatal hospitalization
survival at discharge and survival without severe morbidity
2 secondary outcomes
survival at 2 years of corrected
Time frame: during the first two years corrected age
age without neurosensory impairment
Time frame: during the first two years corrected age
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 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Twin Pregnancy
RecruitingObservational study
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
Fetal Growth Restriction, Cardiac Remodeling, Ventricular
Active, not recruitingObservational study
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
Preterm Birth, Preterm Labor
Recruiting
Lifestyle Intervention to Improve Twin Pregnancy Outcomes
Twin Pregnancy, Dichorionic
Not yet recruiting
MoDi Twin Placental Imaging
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
Active, not recruitingObservational study
Twin Pregnancy Cohort
Pregnant With Complication, Twin Pregnancy With Antenatal Problem
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.
Florent FUCHS, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Pregnancy, run by University Hospital, Montpellier at 1 site 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 5 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 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
survival at discharge and survival (time frame: during neonatal hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2020.