Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins

June 4, 2020 updated by: University Hospital, Montpellier

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Planned vaginal delivery
Other: Survival at discharge
Survival at discharge
Other: Survival without severe morbidity
Survival without severe morbidity (IVH, severe BPD, NEC, ROP)
Planned cesarean delivery
Other: Survival at discharge
Survival at discharge
Other: Survival without severe morbidity
Survival without severe morbidity (IVH, severe BPD, NEC, ROP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival at discharge and survival
Time Frame: during neonatal hospitalization
survival at discharge and survival without severe morbidity
during neonatal hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival at 2 years of corrected
Time Frame: during the first two years corrected age
survival at 2 years of corrected
during the first two years corrected age
age without neurosensory impairment
Time Frame: during the first two years corrected age
age without neurosensory impairment
during the first two years corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Florent FUCHS, PU-PH, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

July 30, 2019

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (ACTUAL)

January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL20_0035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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