Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies

PHASE4CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

March 31, 2016

Study Completion Date

April 30, 2016

Conditions
Early Onset of Delivery Before 37 Weeks
Interventions
DRUG

Vaginal micronized progesterone

200 mg vaginal route per day

DEVICE

Cervical pessary

Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm)

Trial Locations (27)

13005

Ciudad Real General University Hospital, Ciudad Real

17320

Palamos Hospital, Girona

19002

Guadalajara General University Hospital, Guadalajara

20080

Hospital Universitario de Donostia, Donostia / San Sebastian

24071

University Hospital de León, León

28023

Sanitas La Zarzuela Hospital, Madrid

28040

Hospital Infanta Elena, Valdemoro

28046

University Hospital Ramón y Cajal, Madrid

28050

Sanitas La Moraleja Hospital, Madrid

28222

University Hospital Puerta de Hierro, Majadahonda

28660

University Hospital Madrid Monte Principe, Boadilla del Monte

28702

Hospital Infanta Sofía, San Sebastián de los Reyes

28805

University Hospital Príncipe de Asturias, Alcalá de Henarés

28905

University Hospital de Getafe, Getafe

28911

University Hospital Severo Ochoa, Leganés

28922

University Hospital Fundación de Alcorcón, Alcorcón

28933

University Hospital Rey Juan Carlos I, Móstoles

28935

University Hospital Mostoles, Móstoles

28942

University Hospital Fuenlabrada, Fuenlabrada

29004

University Hospital Quirón Málaga, Málaga

47005

Valladolid Clinic Universitary Hospital, Valladolid

47012

University Hospital Rio Hortega, Valladolid

50009

University Hospital Miguel Servet, Zaragoza

03550

University Hospital San Juan de Alicante, Sant Joan d'Alacant

08028

University Hospital Quiron Dexeus, Barcelona

08700

Igualada Hospital, Igualada

09006

Burgos University Hospital, Burgos

All Listed Sponsors
lead

Dra.Cristina Martinez Payo

OTHER

NCT01643980 - Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies | Biotech Hunter | Biotech Hunter