Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins (PECEP-TWINS)
This study is currently recruiting participants.
Verified July 2011 by Maternal-Infantil Vall d´Hebron Hospital
Sponsor:
Maternal-Infantil Vall d´Hebron Hospital
Information provided by:
Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier:
NCT01242410
First received: September 28, 2010
Last updated: July 24, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Preterm Birth |
Device: Silicon ring (Arabin Cervical Pessary) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins |
Further study details as provided by Maternal-Infantil Vall d´Hebron Hospital:
Primary Outcome Measures:
- Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Birth weight [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
- Fetal-Neonatal Death [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
- Neonatal morbidity [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
- Maternal adverse effects [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
- Preterm birth before 37 weeks or 28 weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
- Rupture of membranes before 34 weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
- Hospitalisation for threatened preterm labour [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Expectant Management | |
| Experimental: Placement of cervical pessary since 23 weeks until 37 weeks |
Device: Silicon ring (Arabin Cervical Pessary)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
|
Detailed Description:
This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242410
Contacts
| Contact: Maria M Goya | 934893185 | mariagoya@mac.com |
| Contact: Elena Carreras | 934893072 | ecarrera@vhebron.net |
Locations
| Spain | |
| Hospital Vall d'Herbron | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Maria M Goya 934893185 mariagoya@mac.com | |
Sponsors and Collaborators
Maternal-Infantil Vall d´Hebron Hospital
Investigators
| Study Director: | Elena Carreras | Hospital Vall d'Hebron |
| Principal Investigator: | Maria M Goya | Hospital Vall d'Hebron |
More Information
No publications provided
| Responsible Party: | Elena Carreras Moratonas / PhD, Maternal-Infantil Vall d´Hebron Hospital |
| ClinicalTrials.gov Identifier: | NCT01242410 History of Changes |
| Other Study ID Numbers: | Pessary in twins TRIAL |
| Study First Received: | September 28, 2010 |
| Last Updated: | July 24, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Maternal-Infantil Vall d´Hebron Hospital:
|
Short cervix Preterm birth Cervical pessary Twins |
Additional relevant MeSH terms:
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 21, 2013