Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federico II University | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
Twin pregnancies have 59% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. The transvaginal cervical length (TVCL) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (PTB). When short TVCL is identified before 24 weeks, the risk of preterm birth is 60%-70% for TVCL ≤25mm and 80%-90% for TVCL ≤15mm. There are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. The investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm between 16 to 23 6/7 weeks of gestation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cerclage + vaginal progesterone | Active Comparator | Cervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
|
| Vaginal progesterone | No Intervention | Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical cerclage | Procedure | Cervical cerclage indicated by short cervix ≤15mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm delivery less than 34 weeks | Incidence of preterm birth less than 34 weeks (any indication) | at delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth rates | Incidence of spontaneous preterm birth less than 34 weeks | at delivery |
| Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks | Incidence of preterm birth less than <32 weeks, <28 weeks, or <24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Only pregnant women
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Roman, MD | Contact | 215.955.9200 | amanda.roman@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amanda Roman, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Not yet recruiting | Washington D.C. | District of Columbia | 20052 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23400611 | Result | Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11. | |
| 8885774 | Result | Goldenberg RL, Iams JD, Miodovnik M, Van Dorsten JP, Thurnau G, Bottoms S, Mercer BM, Meis PJ, Moawad AH, Das A, Caritis SN, McNellis D. The preterm prediction study: risk factors in twin gestations. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. 1996 Oct;175(4 Pt 1):1047-53. doi: 10.1016/s0002-9378(96)80051-2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2017 | Apr 14, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2017 | Apr 14, 2020 | ICF_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| at delivery |
| Mean gestational age at delivery | Mean value of gestational age at delivery (weeks) | at delivery |
| Birth weight at birth | Mean value (grams) | at delivery |
| Gestational age at spontaneous rupture of membranes | Mean value (weeks) through study completion | at delivery |
| Premature rupture of membranes | Incidence | at delivery |
| Chorioamnionitis | Incidence | at delivery |
| Composite adverse neonatal outcome | Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis | Incidence between birth and 28 days of age |
| Neonatal death | Incidence | Between birth and 28 days of age |
| Maternal death | Incidence | Between birth and 6 weeks postpartum |
| Interval between diagnosis and delivery | Mean value (days) through study completion | at delivery |
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Austin Maternal Fetal Medicine St David's Health Care | Recruiting | Austin | Texas | 78758 | United States |
|
| The Egyptian IVF Center | Recruiting | Cairo | Egypt |
|
| Bologna University | Recruiting | Bologna | Italy |
|
| University of Brescia | Recruiting | Brescia | Italy |
|
| Università degli Studi di Napoli "Federico II" | Recruiting | Naples | Italy |
|
| University of Barcelona | Recruiting | Barcelona | Spain |
|
| 20576253 | Result | Conde-Agudelo A, Romero R, Hassan SS, Yeo L. Transvaginal sonographic cervical length for the prediction of spontaneous preterm birth in twin pregnancies: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Aug;203(2):128.e1-12. doi: 10.1016/j.ajog.2010.02.064. Epub 2010 Jun 23. |
| 25644964 | Result | Saccone G, Rust O, Althuisius S, Roman A, Berghella V. Cerclage for short cervix in twin pregnancies: systematic review and meta-analysis of randomized trials using individual patient-level data. Acta Obstet Gynecol Scand. 2015 Apr;94(4):352-8. doi: 10.1111/aogs.12600. Epub 2015 Mar 1. |
| 25637840 | Result | Roman A, Rochelson B, Fox NS, Hoffman M, Berghella V, Patel V, Calluzzo I, Saccone G, Fleischer A. Efficacy of ultrasound-indicated cerclage in twin pregnancies. Am J Obstet Gynecol. 2015 Jun;212(6):788.e1-6. doi: 10.1016/j.ajog.2015.01.031. Epub 2015 Jan 28. |
| 28067007 | Result | Romero R, Conde-Agudelo A, El-Refaie W, Rode L, Brizot ML, Cetingoz E, Serra V, Da Fonseca E, Abdelhafez MS, Tabor A, Perales A, Hassan SS, Nicolaides KH. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):303-314. doi: 10.1002/uog.17397. |
| D000091642 | Urogenital Diseases |