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The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (<=25mm) and without prior spontaneous preterm birth
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth <35 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage | Experimental | Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. |
|
| Control | Other | Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical cerclage | Procedure | Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth <35 weeks | Incidence of spontaneous preterm birth less than 35 weeks | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks | At delivery | |
| Mean gestational age at delivery | At delivery | |
| Histologically proven clinical chorioamnionitis |
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Inclusion Criteria:
Exclusion Criteria:
Patients must be pregnant to be enrolled. Self-represented gender identity is NOT a basis of eligibility
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States | ||
| University of Naples Federico II |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28295722 | Background | Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5. | |
| 39880123 |
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IPD will be shared upon completion of appropriate data sharing agreements
1yr after study completion
IPD will be shared upon completion of appropriate data sharing agreements
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Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
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| Vaginal progesterone | Drug | Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks |
|
| At delivery |
| Neonatal outcomes: birth weight | At delivery |
| Neonatal outcomes: low birth weight (<2500g), | At delivery |
| Neonatal outcomes: admission to intensive care nursery | At delivery |
| Neonatal outcomes: length of neonatal hospital admission | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: respiratory distress syndrome | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: IVH grade 3 or 4 | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: retinopathy of prematurity | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: bronchopulmonary dysplasia | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: neonatal mortality | 28 days after delivery |
| Naples |
| Italy |
| University Cattolica del S. Cuore | Rome | Italy |
| Derived |
| Boelig RC, Tersigni C, Di Simone N, Saccone G, Facchinetti F, Scambia G, Berghella V. Cerclage in singleton pregnancies with no prior spontaneous preterm birth and short cervix: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Apr;7(4):101602. doi: 10.1016/j.ajogmf.2025.101602. Epub 2025 Jan 27. |
| 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 |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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