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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.
This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expectant Management | No Intervention | ||
| Placement of cervical pessary since 23 weeks until 37 weeks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicon ring (Arabin Cervical Pessary) | Device | Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous delivery before 34 completed weeks | Each 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | Each 6 months | |
| Fetal-Neonatal Death | Each 6 months | |
| Neonatal morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Carreras | Hospital Vall d'Hebron | Study Director |
| Maria M Goya | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Herbron | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26627728 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Each 6 months |
| Maternal adverse effects | Each 6 months |
| Preterm birth before 37 weeks or 28 weeks | Each 6 months |
| Rupture of membranes before 34 weeks | Each 6 months |
| Hospitalisation for threatened preterm labour | Each 6 months |
| D000091642 | Urogenital Diseases |