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Completed

NCT Number: NCT01242384

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.

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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

Phase 4

Primary location

Hospital Vall d'Herbron

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minimal age of 18 years
  • Episode of threatened preterm labour

Exclusion criteria

  • Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
  • Spontaneous rupture of membranes at the time of randomization
  • Cervical cerclage in situ
  • Active vaginal bleeding
  • Placenta previa

Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).

Treatment and study plan

Device: Silicon ring (Arabin Pessary)

Device

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

Primary outcomes

  1. Spontaneous delivery before 34 completed weeks

    Time frame: Each 6 months

Secondary outcomes

  1. Birth weight

    Time frame: Each 6 months

  2. Fetal-Neonatal Death

    Time frame: Each 6 months

  3. Neonatal morbidity

    Time frame: Each 6 months

  4. Maternal adverse effects

    Time frame: Each 6 months

  5. Preterm birth before 37 weeks or 28 weeks

    Time frame: Each 6 months

  6. Rupture of membranes before 34 weeks

    Time frame: Each 6 months

  7. Hospitalisation for threatened preterm labour

    Time frame: Each 6 months

Sponsors and collaborators

Lead sponsor

Maternal-Infantil Vall d´Hebron Hospital

Other

Registry information

Official study title

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor

Acronym: PECEP-RETARD

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Nov 17, 2010
Registry last updated
Sep 20, 2016

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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