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Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.
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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 |
|---|---|---|---|---|
| Device: Silicon ring (Arabin Pessary) | Device | Placement of a silicon pessary in the vagina, around the cervix. |
|
| 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:
Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).
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| Name | Affiliation | Role |
|---|---|---|
| Elena Carreras | Hospital Vall d'Hebron | Study Director |
| Maria 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 |
|---|---|---|---|
| 36453699 | Derived | Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508. | |
| 30826339 | Derived | Merced C, Goya M, Pratcorona L, Rodo C, Llurba E, Higueras T, Cabero L, Carreras E; PECEP-RETARD Trial Group. Cervical pessary for preventing preterm birth in twin pregnancies with maternal short cervix after an episode of threatened preterm labor: randomised controlled trial. Am J Obstet Gynecol. 2019 Jul;221(1):55.e1-55.e14. doi: 10.1016/j.ajog.2019.02.035. Epub 2019 Feb 28. |
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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 |