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

Preterm Birth Clinical Trial

— PECEP-RETARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242384
• Other study ID #: PECEP-RETARD TRIAL
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: September 18, 2016
• Start date: June 2008
• Est. completion date: July 2014

Study information

• Verified date: September 2016
• Source: Maternal-Infantil Vall d´Hebron Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

Device:
• Device: Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Herbron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Maternal-Infantil Vall d´Hebron Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous delivery before 34 completed weeks		Each 6 months	No
Secondary	Birth weight		Each 6 months	No
Secondary	Fetal-Neonatal Death		Each 6 months	No
Secondary	Neonatal morbidity		Each 6 months	No
Secondary	Maternal adverse effects		Each 6 months	No
Secondary	Preterm birth before 37 weeks or 28 weeks		Each 6 months	No
Secondary	Rupture of membranes before 34 weeks		Each 6 months	No
Secondary	Hospitalisation for threatened preterm labour		Each 6 months	No