EVALUATION OF PROGESTERONE-RELATED COMPOUNDS FOR THE TERZIARY PROPHILAXYS OF PRETERM DELIVERY: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL - PROGESTERONE-RELATED COMPOUNDS AND PRETERM DELIVERY

• Conditions: THREATENED PRETERM DELIVERY; MedDRA version: 9.1Level: SOCClassification code 10036585

• Registration Number: EUCTR2009-017441-63-IT
• Lead Sponsor: .O. Ginecologia e Ostetricia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-11
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women with singleton pregnancy at 22nd to 32nd week of gestation presenting with a cervical length ≤25 mm, even after an episode of preterm labour.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, cervix dilated >2 cm or shorter than 5 mm, presence of regular uterine contractions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This trial would compare the effect of P and 17P in reducing PTD, in women at risk because of cervical shortening.;Secondary Objective: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions before delivery, birth-weight, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications.;Primary end point(s): Delivery before 37 weeks.