Physical Exam Indicated Cerclage in Twin Gestations

Preterm Birth Clinical Trial

— TWIN-PEIC  

Official title:

Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02490384
• Other study ID #: ThomasJeffersonU
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 12, 2019

Study information

• Verified date: April 2020
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 12, 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Pregnant women older than 18 years of age

2. Diamniotic twin pregnancy

3. 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

Exclusion Criteria:

1. Singleton pregnancy or higher order than twins multiple gestation

2. Cervical dilation more than 5 cm

3. Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue

4. More than 24 weeks of gestation

5. Multifetal reduction after 14 weeks

6. Monoamniotic twins

7. Twin-twin transfusion syndrome

8. Ruptured amniotic membranes at the time of diagnosis of dilated cervix

9. Major fetal structural anomaly

10. Fetal chromosomal abnormality

11. Cerclage already in place for other indications

12. Active vaginal bleeding

13. Suspicion of clinical or biochemical chorioamnionitis

14. Painful regular uterine contractions

15. Labor (progressing cervical dilation)

16. Placenta previa

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Physical exam indicated cerclage
Cervical cerclage

Locations

Country	Name	City	State
Italy	Bologna University	Bologna
Italy	University of Brescia	Brescia
Italy	Università degli Studi di Napoli "Federico II"	Naples
Poland	University of Warsaw	Warsaw
United States	Albany Medical Center	Albany	New York
United States	Austin Maternal Fetal Medicine St David's Health Care	Austin	Texas
United States	Wright State University	Dayton	Ohio
United States	Columbia University Medical Center	New York	New York
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	George Washington University	Washington	District of Columbia

Sponsors (13)

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

Countries where clinical trial is conducted

United States,  Italy,  Poland, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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, Cetingöz 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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chorioamnionitis	Incidence	Time of delivery
Other	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
Other	Fetal demise	Incidence	Incidence before delivery
Other	Neonatal death	Incidence	Incidence between birth and 28 days of age
Other	Perinatal death	Incidence	Incidence before and after birth ulntil 28 days of age
Other	Maternal death	Incidence	Between birth and 6 weeks postpartum
Other	Interval between diagnosis and delivery	Mean value (days) through study completion	at delivery
Primary	Preterm delivery less than 34 weeks	Incidence of preterm birth less than 34 weeks (any indication)	at delivery
Secondary	Spontaneous preterm birth less than 34	Incidence of spontaneous preterm birth less than 34 weeks	at delivery
Secondary	Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks	Incidence of preterm birth less than <32 weeks, <28 weeks, or <24 weeks	at delivery
Secondary	Mean gestational age at delivery	Mean value of gestational age at delivery (weeks)	at delivery
Secondary	Birth weight at birth	Mean value (grams)	at delivery
Secondary	Gestational age at spontaneous rupture of membranes	Mean value (weeks) through study completion	at presentation of rupture membranes