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

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Device: Silicon ring (Arabin Pessary)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous Delivery Before 34 Completed Weeks	Number of spontaneous preterm births before 34 weeks occurred in each group.	Between 24 and 34 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birthweight Less Than 1500 g	Number of newborns whose birthweight is less than 1500 grams	Time of delivery
Birthweight Less Than 2500 g	Number of newborns whose birthweight is less than 2500 grams	Time of delivery
Intrauterine Fetal Demise	The number of fetal deaths in the pessary group was compared to those in the no pessary group	Pregnancy
Neonatal Death	The number of neonatal deaths in the pessary group was compared to those in the no pessary group	Between birth and 28 days of age
Intraventricular Haemorrhage	The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group	Between birth and 28 days of age
Respiratory Distress Syndrome	The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group	Between birth and 28 days of age
Retinopathy of Prematurity	The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group	Between birth and 28 days of age
Necrotising Enterocolitis	The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group	Between birth and 28 days of age
Treatment for Sepsis	The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group	Between birth and 28 days of age
Composite Adverse Outcomes	The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group	Between birth and 28 days of age
Spontaneous Delivery Before 28 Completed Weeks	Number of preterm births before 28 weeks occurred in each group.	Between 24 and 28 weeks
Any Delivery Before 34 Completed Weeks	Number of all preterm births before 34 weeks occurred in each group.	Between 24 and 34 weeks
Spontaneous Delivery Before 37 Completed Weeks	Number of preterm births before 37 weeks occurred in each group.	Between 24 and 37 weeks
Gestational Age at Delivery	Number of weeks of gestation completed by time of delivery	At time of birth
Use of Tocolysis	Number of participants required use of tocolytic medication	participants will be followed for the duration of pregnancy, up to nine months
Use of Antenatal Steroids	Number of participants that received betamethasone to reduce morbidity of expected preterm delivery	participants will be followed for the duration of pregnancy, up to nine months
Chorioamnionitis	Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.	participants will be followed for the duration of pregnancy, up to nine months
Vaginal Bleeding	Number of participants who experienced bleeding from lower genital tract during antepartum period	participants will be followed for the duration of pregnancy, up to nine months
Preterm Premature Rupture of Membranes	Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.	participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery	Number of participants that underwent cesarean delivery	At time of delivery
Vaginal Discharge	Number of participants who experienced an increased vaginal discharge.	participants will be followed for the duration of pregnancy, up to nine months
Pessary Repositioning Without Removal	Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).	participants will be followed for the duration of pregnancy, up to nine months
Pessary Withdrawal	Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).	participants will be followed for the duration of pregnancy, up to nine months

Collaborators and Investigators

• Sponsor: Maternal-Infantil Vall d´Hebron Hospital
• Collaborators: Hospital Universitario de Canarias; Institut Universitari Dexeus; Hospital Son Llatzer
• Investigators: Study Director: ELENA CARRERAS, PhD, Maternal-Infantil Vall d´Hebron Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2012 May 12;379(9828):1790.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 24, 2008
• First Submitted That Met QC Criteria: June 26, 2008
• First Posted (Estimate): June 27, 2008

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: preterm birth; Short cervix; arabin pessary
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: PECEP-TRIAL