NCT01242410

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 12, 2015

Status Verified

July 1, 2014

Enrollment Period

3.5 years

First QC Date

September 28, 2010

Last Update Submit

May 9, 2015

Conditions

Preterm Birth

Keywords

Short cervixPreterm birthCervical pessaryTwins

Outcome Measures

Primary Outcomes (1)

  • Spontaneous delivery before 34 completed weeks

    Each 6 months

Secondary Outcomes (7)

  • Birth weight

    Each 6 months

  • Fetal-Neonatal Death

    Each 6 months

  • Neonatal morbidity

    Each 6 months

  • Maternal adverse effects

    Each 6 months

  • Preterm birth before 37 weeks or 28 weeks

    Each 6 months

  • +2 more secondary outcomes

Study Arms (2)

Expectant Management

NO INTERVENTION

Placement of cervical pessary since 23 weeks until 37 weeks

EXPERIMENTAL
Device: Silicon ring (Arabin Cervical Pessary)

Interventions

Silicon ring (Arabin Cervical Pessary)DEVICE

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

Placement of cervical pessary since 23 weeks until 37 weeks

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Twins
  • Minimal age of 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall d'Herbron

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • Goya M, de la Calle M, Pratcorona L, Merced C, Rodo C, Munoz B, Juan M, Serrano A, Llurba E, Higueras T, Carreras E, Cabero L; PECEP-Twins Trial Group. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins). Am J Obstet Gynecol. 2016 Feb;214(2):145-152. doi: 10.1016/j.ajog.2015.11.012. Epub 2015 Nov 25.

    PMID: 26627728DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Elena Carreras

    Hospital Vall d'Hebron

    STUDY DIRECTOR

  • Maria M Goya

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 28, 2010

First Posted

November 17, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 12, 2015

Record last verified: 2014-07

Locations

ES(1)