Cerclage for Twins With Short Cervical Length ≤ 15mm (TWIN-UIC)

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ClinicalTrials.gov Identifier: NCT03340688

Recruitment Status : Recruiting

First Posted : November 13, 2017

Last Update Posted : April 27, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Federico II University

Information provided by (Responsible Party):

Thomas Jefferson University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Twin Pregnancy With Antenatal Problem Preterm Birth Short Cervix	Procedure: Cervical cerclage	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Cervical Cerclage for Preventing Spontaneous Preterm Birth in Twin Pregnancies With Transvaginal Ultrasound Cervical Length ≤ 15mm: a Study Protocol for a Randomized Clinical Trial
Actual Study Start Date :	June 22, 2017
Estimated Primary Completion Date :	June 2024
Estimated Study Completion Date :	June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy Twins, Triplets, Multiple Births

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cervical cerclage + vaginal progesterone Cervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks	Procedure: Cervical cerclage Cervical cerclage indicated by short cervix ≤15mm
No Intervention: Vaginal progesterone Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Outcome Measures

Primary Outcome Measures :

Preterm delivery less than 34 weeks [ Time Frame: at delivery ]
Incidence of preterm birth less than 34 weeks (any indication)

Secondary Outcome Measures :

Spontaneous preterm birth rates [ Time Frame: at delivery ]
Incidence of spontaneous preterm birth less than 34 weeks
Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks [ Time Frame: at delivery ]
Incidence of preterm birth less than <32 weeks, <28 weeks, or <24 weeks
Mean gestational age at delivery [ Time Frame: at delivery ]
Mean value of gestational age at delivery (weeks)
Birth weight at birth [ Time Frame: at delivery ]
Mean value (grams)
Gestational age at spontaneous rupture of membranes [ Time Frame: at delivery ]
Mean value (weeks) through study completion
Premature rupture of membranes [ Time Frame: at delivery ]
Incidence
Chorioamnionitis [ Time Frame: at delivery ]
Incidence
Composite adverse neonatal outcome [ Time Frame: Incidence between birth and 28 days of age ]
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis
Neonatal death [ Time Frame: Between birth and 28 days of age ]
Incidence
Maternal death [ Time Frame: Between birth and 6 weeks postpartum ]
Incidence
Interval between diagnosis and delivery [ Time Frame: at delivery ]
Mean value (days) through study completion

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Only pregnant women
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant women more than 18 years of age (limits the participants to female gender)
Diamniotic twin pregnancy
Asymptomatic
Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation

Exclusion Criteria:

Singleton or higher order than twins multiple gestation
Transvaginal cervical length >15mm
Cervical dilation with visible amniotic membranes
Amniotic membranes prolapsed into the vagina
Fetal reduction after 14 weeks form higher order
Monoamniotic twins
Twin-twin transfusion syndrome
Ruptured membranes
Major fetal structural anomaly
Fetal chromosomal abnormality
Cerclage already in place for other indication
Active vaginal bleeding
Clinical chorioamnionitis
Placenta previa
Painful regular uterine contractions
Labor

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340688

Contacts

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Contact: Amanda Roman, MD	215.955.9200	amanda.roman@jefferson.edu

Locations

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United States, District of Columbia
George Washington University	Not yet recruiting
Washington, District of Columbia, United States, 20052
Contact: Alexis Gimovsky, MD agimovsky@gmail.com
United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Amanda Roman, MD 215-955-9200 amanda.roman@jefferson.edu
Contact: MD
United States, Texas
Austin Maternal Fetal Medicine St David's Health Care	Recruiting
Austin, Texas, United States, 78758
Contact: Sina Haeri, MD
Contact sinahaeri@gmail.com
Egypt
The Egyptian IVF Center	Recruiting
Cairo, Egypt
Contact: Mona Aboulghar, MD monaaboulghar71@gmail.com
Contact: Yahia EL faissal, MD yahiaelfaissal@gmail.com
Italy
Bologna University	Recruiting
Bologna, Italy
Contact: Giuliana Simonazzi, MD giuliana.simonazzi@unibo.it
Contact: Nicola Rizzo nicola.rizzo@unibo.it
University of Brescia	Recruiting
Brescia, Italy
Contact: Anna Fichera, MD anna.fichera@gmail.com
Contact: Federico Prefumo, MD federico.prefumo@gmail.com
Università degli Studi di Napoli "Federico II"	Recruiting
Naples, Italy
Contact: Gabriele Saccone, MD gabriele.saccone@libero.it
Contact: Pasquale Martinelli, MD martinel@unina.it
Spain
University of Barcelona	Recruiting
Barcelona, Spain
Contact: Núria Baños, MD NBANOS@clinic.cat

Sponsors and Collaborators

Thomas Jefferson University

Federico II University

Investigators

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Principal Investigator:	Amanda Roman, MD	Thomas Jefferson University

Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:

Study Protocol and Statistical Analysis Plan [PDF] May 22, 2017

Informed Consent Form [PDF] June 22, 2017

More Information

Publications of Results:

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.

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.

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.

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.

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.

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. Review.

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Responsible Party:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT03340688
Other Study ID Numbers:	17D.326
First Posted:	November 13, 2017 Key Record Dates
Last Update Posted:	April 27, 2020
Last Verified:	April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications

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