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

Preterm Birth Clinical Trial

— PECEP-TWINS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242410
• Other study ID #: Pessary in twins TRIAL
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: May 9, 2015
• Start date: January 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• 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 twins and a short cervical length at 18-22 weeks scan.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• 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:

• Twins

• Minimal age of 18 years

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

Study Design

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Silicon ring (Arabin Cervical Pessary)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

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