Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins

Twin Pregnancy Clinical Trial

Official title:

Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232436
• Other study ID #: RECHMPL20_0035
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 1, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Twin Pregnancy

Intervention

Other:
• Survival at discharge
Survival at discharge
• Survival without severe morbidity
Survival without severe morbidity (IVH, severe BPD, NEC, ROP)

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival at discharge and survival	survival at discharge and survival without severe morbidity	during neonatal hospitalization
Secondary	survival at 2 years of corrected	survival at 2 years of corrected	during the first two years corrected age
Secondary	age without neurosensory impairment	age without neurosensory impairment	during the first two years corrected age