Physical Exam Indicated Cerclage in Twin Gestations

NCT02490384 | Terminated DMC

• 1 other identifier: ThomasJeffersonU
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 11

Brief Summary

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.

Conditions

Twin Pregnancy, Antepartum Condition or Complication; Preterm Birth; Cervical Dilation Premature

Keywords

Cervical cerclage

Outcome Measures

Primary Outcomes (1)

• Preterm delivery less than 34 weeks

  Incidence of preterm birth less than 34 weeks (any indication)

  at delivery

Secondary Outcomes (5)

• Spontaneous preterm birth less than 34

  at delivery

• Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks

  at delivery

• Mean gestational age at delivery

  at delivery

• Birth weight at birth

  at delivery

• Gestational age at spontaneous rupture of membranes

  at presentation of rupture membranes

Other Outcomes (7)

• Chorioamnionitis

  Time of delivery

• Composite adverse neonatal outcome

  Incidence between birth and 28 days of age

• Fetal demise

  Incidence before delivery

Study Arms (2)

Physical exam indicated cerclage

ACTIVE COMPARATOR

Cerclage

Procedure: Physical exam indicated cerclage

Expectant management

NO INTERVENTION

No cerclage

Interventions

Physical exam indicated cerclage PROCEDURE

Cervical cerclage

Physical exam indicated cerclage

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women older than 18 years of age
• Diamniotic twin pregnancy
• Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation

You may not qualify if:

• Singleton pregnancy or higher order than twins multiple gestation
• Cervical dilation more than 5 cm
• Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
• More than 24 weeks of gestation
• Multifetal reduction after 14 weeks
• Monoamniotic twins
• Twin-twin transfusion syndrome
• Ruptured amniotic membranes at the time of diagnosis of dilated cervix
• Major fetal structural anomaly
• Fetal chromosomal abnormality
• Cerclage already in place for other indications
• Active vaginal bleeding
• Suspicion of clinical or biochemical chorioamnionitis
• Painful regular uterine contractions
• Labor (progressing cervical dilation)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Columbia University: collaborator
• Federico II University: collaborator
• Albany Medical College: collaborator
• University of Rochester: collaborator
• George Washington University: collaborator
• Wright State University: collaborator
• Baystate Medical Center: collaborator
• Università degli Studi di Brescia: collaborator
• University of Bologna: collaborator
• University Hospital, Geneva: collaborator
• University of Warsaw: collaborator
• Maternal Fetal Medicine Associates: collaborator

Study Sites (11)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wright State University

Dayton, Ohio, 45409, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Austin Maternal Fetal Medicine St David's Health Care

Austin, Texas, 78758, United States

Location

Bologna University

Bologna, Italy

Location

University of Brescia

Brescia, Italy

Location

Università degli Studi di Napoli "Federico II"

Naples, Italy

Location

University of Warsaw

Warsaw, Poland

Location

Related Publications (17)

• 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.

  PMID: 23400611 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.

  PMID: 8885774 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.

  PMID: 20576253 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.

  PMID: 17671253 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.

  PMID: 22420582 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.

  PMID: 22284156 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.

  PMID: 25644964 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.

  PMID: 25637840 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.

  PMID: 24321466 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.

  PMID: 19883267 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.

  PMID: 23430029 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.

  PMID: 24657791 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.

  PMID: 24972530 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.

  PMID: 23924878 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.

  PMID: 14586323 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.

  PMID: 26827881 BACKGROUND

• 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.

  PMID: 32592693 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amanda Roman, MD

  amanda.roman@jefferson.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 3, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 12, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: June 2020 2 years
• Access Criteria: x

Locations

IT (3); PL (1); US (7)