NCT04232436

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 5, 2020

Status Verified

January 1, 2020

Enrollment Period

29 days

First QC Date

January 14, 2020

Last Update Submit

June 4, 2020

Conditions

Twin Pregnancy

Keywords

Mode of deliveryPrematuritySurvival at dischargeSurvival without severe morbidity

Outcome Measures

Primary Outcomes (1)

  • survival at discharge and survival

    survival at discharge and survival without severe morbidity

    during neonatal hospitalization

Secondary Outcomes (2)

  • survival at 2 years of corrected

    during the first two years corrected age

  • age without neurosensory impairment

    during the first two years corrected age

Study Arms (2)

Planned vaginal delivery

Planned vaginal delivery

Other: Survival at dischargeOther: Survival without severe morbidity

Planned cesarean delivery

Planned cesarean delivery

Other: Survival at dischargeOther: Survival without severe morbidity

Interventions

Survival at dischargeOTHER

Survival at discharge

Planned cesarean deliveryPlanned vaginal delivery
Survival without severe morbidityOTHER

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

Planned cesarean deliveryPlanned vaginal delivery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Florent FUCHS, PU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

July 1, 2019

Primary Completion

July 30, 2019

Study Completion

March 1, 2020

Last Updated

June 5, 2020

Record last verified: 2020-01

Locations

FR(1)