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

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ClinicalTrials.gov Identifier: NCT00706264
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
Hospital Universitario de Canarias
Hospital Son Llatzer
Institut Universitari Dexeus
Information provided by (Responsible Party):
Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2008
First Posted Date  ICMJE June 27, 2008
Results First Submitted Date  ICMJE February 11, 2018
Results First Posted Date  ICMJE March 17, 2021
Last Update Posted Date March 17, 2021
Study Start Date  ICMJE June 2007
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
Spontaneous Delivery Before 34 Completed Weeks [ Time Frame: Between 24 and 34 weeks ]
Number of spontaneous preterm births before 34 weeks occurred in each group.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
  • Birthweight Less Than 1500 g [ Time Frame: Time of delivery ]
    Number of newborns whose birthweight is less than 1500 grams
  • Birthweight Less Than 2500 g [ Time Frame: Time of delivery ]
    Number of newborns whose birthweight is less than 2500 grams
  • Intrauterine Fetal Demise [ Time Frame: Pregnancy ]
    The number of fetal deaths in the pessary group was compared to those in the no pessary group
  • Neonatal Death [ Time Frame: Between birth and 28 days of age ]
    The number of neonatal deaths in the pessary group was compared to those in the no pessary group
  • Intraventricular Haemorrhage [ Time Frame: Between birth and 28 days of age ]
    The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
  • Respiratory Distress Syndrome [ Time Frame: Between birth and 28 days of age ]
    The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
  • Retinopathy of Prematurity [ Time Frame: Between birth and 28 days of age ]
    The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
  • Necrotising Enterocolitis [ Time Frame: Between birth and 28 days of age ]
    The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
  • Treatment for Sepsis [ Time Frame: Between birth and 28 days of age ]
    The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
  • Composite Adverse Outcomes [ Time Frame: Between birth and 28 days of age ]
    The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
  • Spontaneous Delivery Before 28 Completed Weeks [ Time Frame: Between 24 and 28 weeks ]
    Number of preterm births before 28 weeks occurred in each group.
  • Any Delivery Before 34 Completed Weeks [ Time Frame: Between 24 and 34 weeks ]
    Number of all preterm births before 34 weeks occurred in each group.
  • Spontaneous Delivery Before 37 Completed Weeks [ Time Frame: Between 24 and 37 weeks ]
    Number of preterm births before 37 weeks occurred in each group.
  • Gestational Age at Delivery [ Time Frame: At time of birth ]
    Number of weeks of gestation completed by time of delivery
  • Use of Tocolysis [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    Number of participants required use of tocolytic medication
  • Use of Antenatal Steroids [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
  • Chorioamnionitis [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
  • Vaginal Bleeding [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    Number of participants who experienced bleeding from lower genital tract during antepartum period
  • Preterm Premature Rupture of Membranes [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
  • Cesarean Delivery [ Time Frame: At time of delivery ]
    Number of participants that underwent cesarean delivery
  • Vaginal Discharge [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    Number of participants who experienced an increased vaginal discharge.
  • Pessary Repositioning Without Removal [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    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).
  • Pessary Withdrawal [ Time Frame: participants will be followed for the duration of pregnancy, up to nine months ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
Official Title  ICMJE Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Preterm Birth
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: 1
    Expectant management
  • Experimental: 2
    Placement of arabin pessary since 23 weeks until 37 weeks
    Intervention: Device: Silicon ring (Arabin Pessary)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2021)
385
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2008)
2780
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00706264
Other Study ID Numbers  ICMJE PECEP-TRIAL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
Original Responsible Party Elena Carreras Moratonas / PhD, Maternal-Infantil Vall d´Hebron Hospital
Current Study Sponsor  ICMJE Maternal-Infantil Vall d´Hebron Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Hospital Universitario de Canarias
  • Hospital Son Llatzer
  • Institut Universitari Dexeus
Investigators  ICMJE
Study Director: ELENA CARRERAS, PhD Maternal-Infantil Vall d´Hebron Hospital
PRS Account Maternal-Infantil Vall d´Hebron Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP