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Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins (PECEP-TWINS)

Primary Purpose

Preterm Birth

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Silicon ring (Arabin Cervical Pessary)

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Short cervix, Preterm birth, Cervical pessary, Twins

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital Vall d'Herbron

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Expectant Management

Placement of cervical pessary since 23 weeks until 37 weeks

Arm Description

Outcomes

Primary Outcome Measures

Spontaneous delivery before 34 completed weeks

Secondary Outcome Measures

Birth weight

Fetal-Neonatal Death

Neonatal morbidity

Maternal adverse effects

Preterm birth before 37 weeks or 28 weeks

Rupture of membranes before 34 weeks

Hospitalisation for threatened preterm labour

Full Information

NCT ID

NCT01242410

First Posted

September 28, 2010

Last Updated

May 9, 2015

Sponsor

Maternal-Infantil Vall d´Hebron Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01242410

Brief Title

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

Acronym

PECEP-TWINS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maternal-Infantil Vall d´Hebron Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Birth

Keywords

Short cervix, Preterm birth, Cervical pessary, Twins

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Expectant Management

Arm Type

No Intervention

Arm Title

Placement of cervical pessary since 23 weeks until 37 weeks

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Silicon ring (Arabin Cervical Pessary)

Intervention Description

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

Primary Outcome Measure Information:

Title

Spontaneous delivery before 34 completed weeks

Time Frame

Each 6 months

Secondary Outcome Measure Information:

Title

Birth weight

Time Frame

Each 6 months

Title

Fetal-Neonatal Death

Time Frame

Each 6 months

Title

Neonatal morbidity

Time Frame

Each 6 months

Title

Maternal adverse effects

Time Frame

Each 6 months

Title

Preterm birth before 37 weeks or 28 weeks

Time Frame

Each 6 months

Title

Rupture of membranes before 34 weeks

Time Frame

Each 6 months

Title

Hospitalisation for threatened preterm labour

Time Frame

Each 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elena Carreras

Organizational Affiliation

Hospital Vall d'Hebron

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Maria M Goya

Organizational Affiliation

Hospital Vall d'Hebron

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Vall d'Herbron

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

26627728

Citation

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.

Results Reference

derived

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

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