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NCT Number: NCT00706264

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Materno-Infantil de Canarias, Las Palmas de Gran Canaria, Gran Canaria, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silicon ring (Arabin Pessary)

Device

Placement of a silicon pessary in the vagina, around the cervix.

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Maternal-Infantil Vall d´Hebron Hospital

Other

Collaborators

  • Fundacion Dexeus
  • Hospital Son Llatzer
  • Hospital Universitario de Canarias

Registry information

Official study title

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

Acronym: PECEP

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2008
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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