CClinicalTrials.gg
CompletedNCT04232436Updated Jun 5, 2020

Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins

An observational study in Twin Pregnancy, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to female participants. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
204
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Twin Pregnancy

Keywords

  • Mode of delivery
  • Prematurity
  • Survival at discharge
  • Survival without severe morbidity
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Twins born at Montpellier University Hospital between 24SA and 32SA+6

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
204 participants (actual)
Patient registry
No

Groups and cohorts

  • Planned vaginal delivery

    Planned vaginal delivery

    Other: Survival at discharge · Other: Survival without severe morbidity

  • Planned cesarean delivery

    Planned cesarean delivery

    Other: Survival at discharge · Other: Survival without severe morbidity

Interventions

  • OtherSurvival at discharge

    Survival at discharge

  • OtherSurvival without severe morbidity

    Survival without severe morbidity (IVH, severe BPD, NEC, ROP)

06

What researchers measure

Primary outcomes

  1. survival at discharge and survival

    survival at discharge and survival without severe morbidity

    Time frame: during neonatal hospitalization

Secondary outcomes

  1. survival at 2 years of corrected

    survival at 2 years of corrected

    Time frame: during the first two years corrected age

  2. age without neurosensory impairment

    age without neurosensory impairment

    Time frame: during the first two years corrected age

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04232436
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jan 18, 2020
Start date
Jul 1, 2019
Primary completion
Jul 30, 2019
Completion
Mar 1, 2020
Last update
Jun 5, 2020

Study contacts

Florent FUCHS, PU-PH
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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