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OpenTrials
Completed

NCT Number: NCT04232436

Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Survival at discharge

Other

Survival at discharge

Survival without severe morbidity

Other

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

Primary outcomes

  1. survival at discharge and survival

    Time frame: during neonatal hospitalization

    survival at discharge and survival without severe morbidity

Secondary outcomes

  1. survival at 2 years of corrected

    Time frame: during the first two years corrected age

    survival at 2 years of corrected

  2. age without neurosensory impairment

    Time frame: during the first two years corrected age

    age without neurosensory impairment

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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