Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)

This study has been completed.

Sponsor:

Collaborators:

Hospital Materno-Infantil de Canarias

Hospital Son Llatzer

Institut Universitari Dexeus

Information provided by (Responsible Party):

Elena Carreras, Maria Goya, Maternal-Infantil Vall d´Hebron Hospital

ClinicalTrials.gov Identifier:

NCT00706264

First received: June 24, 2008

Last updated: July 25, 2014

Last verified: July 2014

History of Changes

Purpose

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.

Condition	Intervention	Phase
Preterm Birth	Device: Silicon ring (Arabin Pessary)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)

Further study details as provided by Maternal-Infantil Vall d´Hebron Hospital:

Primary Outcome Measures:

Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Birth weight, Fetal or Neonatal Death, Neonatal morbidity, Maternal adverse effects , Preterm birth before 37 weeks or 28 weeks, Rupture of membranes before 34 weeks, Hospitalisation for threatened preterm labour. [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]


Enrollment:	2780
Study Start Date:	June 2007
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Expectant management
Experimental: 2 Placement of arabin pessary since 23 weeks until 37 weeks	Device: Silicon ring (Arabin Pessary) Placement of a silicon pessary in the vagina, around the cervix. Other Name: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

Detailed Description:

This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Singleton pregnancy
Minimal age of 18 years

Exclusion Criteria:

Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
SROM at the time of randomization
Cervical cerclage in situ
Active vaginal bleeding
Previous cone biopsy or cerclage
Major uterine structural anomalies
Placenta previa

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706264

Locations


Spain
Hospital Materno-Infantil de Canarias
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
Hospital de Reus
Reus, Tarragona, Spain
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Institut Universitary Dexeus
Barcelona, Spain
Hospital de Fuenlabrada
Madrid, Spain
Hospital Son Llàtzer
Mallorca, Spain, 07198

Sponsors and Collaborators

Maternal-Infantil Vall d´Hebron Hospital

Hospital Materno-Infantil de Canarias

Hospital Son Llatzer

Institut Universitari Dexeus

Investigators


Study Director:	ELENA CARRERAS, PhD	Maternal-Infantil Vall d´Hebron Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goya M, Pratcorona L, Merced C, Rodó C, Valle L, Romero A, Juan M, Rodríguez A, Muñoz B, Santacruz B, Bello-Muñoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3. Erratum in: Lancet. 2012 May 12;379(9828):1790.


Responsible Party:	Elena Carreras, Maria Goya, PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier:	NCT00706264 History of Changes
Other Study ID Numbers:	PECEP-TRIAL
Study First Received:	June 24, 2008
Last Updated:	July 25, 2014
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Maternal-Infantil Vall d´Hebron Hospital:


Short cervix preterm birth arabin pessary

Additional relevant MeSH terms:


Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Silicon	Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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