Status:

COMPLETED

Progestagens for the Tertiary Prophylaxis of Preterm Delivery

Lead Sponsor:

University of Modena and Reggio Emilia

Conditions:

Preterm Delivery

Neonatal Complications

Eligibility:

FEMALE

Phase:

PHASE3

Brief Summary

Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and 17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of cervical shortening, in th...

Detailed Description

Background: According to the last reviews Progesterone (P) and (17P) are able to reduce preterm delivery (PTD), either as prophylactic administration in the presence of previous PTD or as a treatment ...

Eligibility Criteria

Inclusion

  • Women with singleton pregnancy at 22+0nd to 31+6nd week of gestation presenting with a cervical length ≤25 mm, after an episode of preterm labour.

Exclusion

  • Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, mullerian malformations, cervical surgery (cervical cerclage etc), presence of regular uterine contractions

Key Trial Info

Start Date :

February 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2015

Estimated Enrollment :

254 Patients enrolled

Trial Details

Trial ID

NCT01178788

Start Date

February 1 2010

End Date

December 1 2015

Last Update

September 23 2016

Active Locations (1)

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University of Modena and Reggio Emilia

Modena, Italy, 41100