NCT00706264

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

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

Study Start

First participant enrolled

June 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
6 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
6.7 years until next milestone

Results Posted

Study results publicly available

March 17, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

7.1 years

First QC Date

June 24, 2008

Results QC Date

February 11, 2018

Last Update Submit

March 16, 2021

Conditions

Preterm Birth

Keywords

Short cervixpreterm birtharabin pessary

Outcome Measures

Primary Outcomes (1)

  • Spontaneous Delivery Before 34 Completed Weeks

    Number of spontaneous preterm births before 34 weeks occurred in each group.

    Between 24 and 34 weeks

Secondary Outcomes (23)

  • Birthweight Less Than 1500 g

    Time of delivery

  • Birthweight Less Than 2500 g

    Time of delivery

  • Intrauterine Fetal Demise

    Pregnancy

  • Neonatal Death

    Between birth and 28 days of age

  • Intraventricular Haemorrhage

    Between birth and 28 days of age

  • +18 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

Expectant management

2

EXPERIMENTAL

Placement of arabin pessary since 23 weeks until 37 weeks

Device: Silicon ring (Arabin Pessary)

Interventions

Silicon ring (Arabin Pessary)DEVICE

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

Also known as: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
2

Eligibility Criteria

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

You may qualify if:

  • Singleton pregnancy
  • Minimal age of 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Materno-Infantil de Canarias

Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital de Reus

Reus, Tarragona, Spain

Location

Hospital Vall d´Hebron

Barcelona, 08035, Spain

Location

Institut Universitary Dexeus

Barcelona, Spain

Location

Hospital de Fuenlabrada

Madrid, Spain

Location

Related Publications (1)

  • Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3.

    PMID: 22475493DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Maria M Goya
Organization
Hospital Vall d'Hebron
maria.goya@vhir.org
934893085

Study Officials

  • ELENA CARRERAS, PhD

    Maternal-Infantil Vall d´Hebron Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
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

June 24, 2008

First Posted

June 27, 2008

Study Start

June 1, 2007

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 17, 2021

Results First Posted

March 17, 2021

Record last verified: 2021-03

Locations

ES(6)