Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery

PHASE2CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

September 2, 2013

Primary Completion Date

March 13, 2017

Study Completion Date

March 13, 2017

Conditions
Preterm Birth
Interventions
DRUG

Progesterone Cervical Pessary 6.3 g

Progesterone Cervical Pessary low dose

DRUG

Progesterone 200 mg vaginal capsules

Progesterone 200 mg vaginal capsules daily

DRUG

Progesterone Cervical Pessary 7.7 g

Progesterone Cervical Pessary high dose

Trial Locations (4)

7501257

Universidad de Chile, Hospital Barros Luco, Santiago

Unknown

Complejo Asistencial Dr. Sótero del Río (CASR), Santiago

Unidad de Alto Riesgo Obstétrico y Medicina Perinatal y en el Centro Perinatal Oriente (CERPO), Hospital Santiago Oriente, Dr. Luis Tisné Brousse, Santiago

Universidad de Chile, Hospital Clínico San Borja Arriarán, Santiago

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Laboratorios Andromaco S.A.

INDUSTRY

lead

Grünenthal GmbH

INDUSTRY