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due to significant decrease of perinatal mortality in the cerclage group
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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Federico II University | OTHER |
| Albany Medical College | OTHER |
| University of Rochester |
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This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.
Twin pregnancies have 58% 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. When cervical dilation is identified before 24 weeks in singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%. Cervical dilation is the worst prognostic factor for preterm birth. There are a small number of case reports of cervical cerclage in twin pregnancies with a dilated cervix that suggest similar outcomes to those in singleton pregnancies. The investigators' objective is to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical exam indicated cerclage | Active Comparator | Cerclage |
|
| Expectant management | No Intervention | No cerclage |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exam indicated cerclage | Procedure | Cervical cerclage |
|
| 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 less than 34 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Chorioamnionitis | Incidence | Time of delivery |
| Composite adverse neonatal outcome | Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Roman, MD | amanda.roman@jefferson.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| Albany Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23400611 | Background | 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 | Background | 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. |
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De identified data
June 2020 2 years
x
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| 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 | Feb 20, 2015 |
| OTHER |
| George Washington University | OTHER |
| Wright State University | OTHER |
| Baystate Medical Center | OTHER |
| Università degli Studi di Brescia | OTHER |
| University of Bologna | OTHER |
| University Hospital, Geneva | OTHER |
| University of Warsaw | OTHER |
| Maternal Fetal Medicine Associates | OTHER |
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| 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 presentation of rupture membranes |
| Incidence between birth and 28 days of age |
| Fetal demise | Incidence | Incidence before delivery |
| Neonatal death | Incidence | Incidence between birth and 28 days of age |
| Perinatal death | Incidence | Incidence before and after birth ulntil 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 |
| Albany |
| New York |
| 12208 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Wright State University | Dayton | Ohio | 45409 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Austin Maternal Fetal Medicine St David's Health Care | Austin | Texas | 78758 | United States |
| Bologna University | Bologna | Italy |
| University of Brescia | Brescia | Italy |
| Università degli Studi di Napoli "Federico II" | Naples | Italy |
| University of Warsaw | Warsaw | Poland |
| 20576253 | Background | 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. |
| 17671253 | Background | Rouse DJ, Caritis SN, Peaceman AM, Sciscione A, Thom EA, Spong CY, Varner M, Malone F, Iams JD, Mercer BM, Thorp J, Sorokin Y, Carpenter M, Lo J, Ramin S, Harper M, Anderson G; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins. N Engl J Med. 2007 Aug 2;357(5):454-61. doi: 10.1056/NEJMoa070641. |
| 22420582 | Background | Schuit E, Stock S, Groenwold RH, Maurel K, Combs CA, Garite T, Spong CY, Thom EA, Rouse DJ, Caritis SN, Saade GR, Zachary JM, Norman JE, Rode L, Klein K, Tabor A, Cetingoz E, Morrison JC, Magann EF, Briery CM, Serra V, Perales A, Meseguer J, Nassar AH, Lim AC, Moons KG, Kwee A, Mol BW. Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials. BMC Pregnancy Childbirth. 2012 Mar 15;12:13. doi: 10.1186/1471-2393-12-13. |
| 22284156 | Background | Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11. |
| 25644964 | Background | 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 | Background | 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. |
| 24321466 | Background | Rebarber A, Bender S, Silverstein M, Saltzman DH, Klauser CK, Fox NS. Outcomes of emergency or physical examination-indicated cerclage in twin pregnancies compared to singleton pregnancies. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:43-7. doi: 10.1016/j.ejogrb.2013.11.016. Epub 2013 Nov 28. |
| 19883267 | Background | Gupta M, Emary K, Impey L. Emergency cervical cerclage: predictors of success. J Matern Fetal Neonatal Med. 2010 Jul;23(7):670-4. doi: 10.3109/14767050903387011. |
| 23430029 | Background | Zanardini C, Pagani G, Fichera A, Prefumo F, Frusca T. Cervical cerclage in twin pregnancies. Arch Gynecol Obstet. 2013 Aug;288(2):267-71. doi: 10.1007/s00404-013-2758-3. Epub 2013 Feb 21. |
| 24657791 | Background | Miller ES, Rajan PV, Grobman WA. Outcomes after physical examination-indicated cerclage in twin gestations. Am J Obstet Gynecol. 2014 Jul;211(1):46.e1-5. doi: 10.1016/j.ajog.2014.03.034. Epub 2014 Mar 18. |
| 24972530 | Background | Berghella V, Roman A. Cerclage in twins: we can do better! Am J Obstet Gynecol. 2014 Jul;211(1):5-6. doi: 10.1016/j.ajog.2014.03.037. No abstract available. |
| 23924878 | Background | Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5. |
| 14586323 | Background | Althuisius SM, Dekker GA, Hummel P, van Geijn HP; Cervical incompetence prevention randomized cerclage trial. Cervical incompetence prevention randomized cerclage trial: emergency cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol. 2003 Oct;189(4):907-10. doi: 10.1067/s0002-9378(03)00718-x. |
| 26827881 | Background | Roman A, Rochelson B, Martinelli P, Saccone G, Harris K, Zork N, Spiel M, O'Brien K, Calluzzo I, Palomares K, Rosen T, Berghella V, Fleischer A. Cerclage in twin pregnancy with dilated cervix between 16 to 24 weeks of gestation: retrospective cohort study. Am J Obstet Gynecol. 2016 Jul;215(1):98.e1-98.e11. doi: 10.1016/j.ajog.2016.01.172. Epub 2016 Jan 28. |
| 32592693 | Derived | Roman A, Zork N, Haeri S, Schoen CN, Saccone G, Colihan S, Zelig C, Gimovsky AC, Seligman NS, Zullo F, Berghella V. Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial. Am J Obstet Gynecol. 2020 Dec;223(6):902.e1-902.e11. doi: 10.1016/j.ajog.2020.06.047. Epub 2020 Jun 25. |
| Apr 14, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2015 | Apr 14, 2020 | ICF_001.pdf |
| 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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