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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

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Device: Silicon ring (Arabin Pessary) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
Study Start Date : June 2007
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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 Name: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Birthweight Less Than 1500 g [ Time Frame: Time of delivery ]
    Number of newborns whose birthweight is less than 1500 grams

  2. Birthweight Less Than 2500 g [ Time Frame: Time of delivery ]
    Number of newborns whose birthweight is less than 2500 grams

  3. Intrauterine Fetal Demise [ Time Frame: Pregnancy ]
    The number of fetal deaths in the pessary group was compared to those in the no pessary group

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Spontaneous Delivery Before 28 Completed Weeks [ Time Frame: Between 24 and 28 weeks ]
    Number of preterm births before 28 weeks occurred in each group.

  12. 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.

  13. Spontaneous Delivery Before 37 Completed Weeks [ Time Frame: Between 24 and 37 weeks ]
    Number of preterm births before 37 weeks occurred in each group.

  14. Gestational Age at Delivery [ Time Frame: At time of birth ]
    Number of weeks of gestation completed by time of delivery

  15. 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

  16. 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

  17. 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.

  18. 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

  19. 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.

  20. Cesarean Delivery [ Time Frame: At time of delivery ]
    Number of participants that underwent cesarean delivery

  21. 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.

  22. 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).

  23. 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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706264


Locations
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Spain
Hospital Materno-Infantil de Canarias
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain, 07198
Hospital de Reus
Reus, Tarragona, Spain
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Institut Universitary Dexeus
Barcelona, Spain
Hospital de Fuenlabrada
Madrid, Spain
Sponsors and Collaborators
Maternal-Infantil Vall d´Hebron Hospital
Hospital Universitario de Canarias
Hospital Son Llatzer
Institut Universitari Dexeus
Investigators
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Study Director: ELENA CARRERAS, PhD Maternal-Infantil Vall d´Hebron Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Goya, MD, PhD, PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT00706264    
Other Study ID Numbers: PECEP-TRIAL
First Posted: June 27, 2008    Key Record Dates
Results First Posted: March 17, 2021
Last Update Posted: March 17, 2021
Last Verified: March 2021
Keywords provided by Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital:
Short cervix
preterm birth
arabin pessary
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Silicon
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs