Clinical trial NCT00706264: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
Official title: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Short cervix
preterm birth
arabin pessary
Lead sponsor: Maternal-Infantil Vall d´Hebron Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Canarias
name: Hospital Son Llatzer
name: Fundacion Dexeus
First posted: 2008-06-27
Enrollment: 385
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility 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

Primary outcomes:
measure: Spontaneous Delivery Before 34 Completed Weeks
timeFrame: Between 24 and 34 weeks
Secondary outcomes:
measure: Birthweight Less Than 1500 g
timeFrame: Time of delivery
measure: Birthweight Less Than 2500 g
timeFrame: Time of delivery
measure: Intrauterine Fetal Demise
timeFrame: Pregnancy
measure: Neonatal Death
timeFrame: Between birth and 28 days of age
measure: Intraventricular Haemorrhage
timeFrame: Between birth and 28 days of age
measure: Respiratory Distress Syndrome
timeFrame: Between birth and 28 days of age
measure: Retinopathy of Prematurity
timeFrame: Between birth and 28 days of age
measure: Necrotising Enterocolitis
timeFrame: Between birth and 28 days of age
measure: Treatment for Sepsis
timeFrame: Between birth and 28 days of age
measure: Composite Adverse Outcomes
timeFrame: Between birth and 28 days of age
measure: Spontaneous Delivery Before 28 Completed Weeks
timeFrame: Between 24 and 28 weeks
measure: Any Delivery Before 34 Completed Weeks
timeFrame: Between 24 and 34 weeks
measure: Spontaneous Delivery Before 37 Completed Weeks
timeFrame: Between 24 and 37 weeks
measure: Gestational Age at Delivery
timeFrame: At time of birth
measure: Use of Tocolysis
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Use of Antenatal Steroids
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Chorioamnionitis
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Vaginal Bleeding
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Preterm Premature Rupture of Membranes
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Cesarean Delivery
timeFrame: At time of delivery
measure: Vaginal Discharge
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Pessary Repositioning Without Removal
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Pessary Withdrawal
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Materno-Infantil de Canarias
state: Gran Canaria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Mallorca
city: Reus
country: Spain
facility: Hospital de Reus
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Barcelona
country: Spain
facility: Institut Universitary Dexeus
city: Madrid
country: Spain
facility: Hospital de Fuenlabrada
Study officials:
affiliation: Maternal-Infantil Vall d´Hebron Hospital
name: ELENA CARRERAS, PhD
role: STUDY_DIRECTOR
References:
citation: Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz 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.