NCT03340688

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

6.9 years

First QC Date

November 8, 2017

Last Update Submit

April 23, 2020

Conditions

Twin Pregnancy With Antenatal ProblemPreterm BirthShort Cervix

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 (11)

  • Spontaneous preterm birth rates

    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 delivery

  • +6 more secondary outcomes

Study Arms (2)

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

Procedure: Cervical cerclage

Vaginal progesterone

NO INTERVENTION

Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Interventions

Cervical cerclagePROCEDURE

Cervical cerclage indicated by short cervix ≤15mm

Cervical cerclage + vaginal progesterone

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

George Washington University

Washington D.C., District of Columbia, 20052, United States

NOT YET RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Austin Maternal Fetal Medicine St David's Health Care

Austin, Texas, 78758, United States

RECRUITING

The Egyptian IVF Center

Cairo, Egypt

RECRUITING

Bologna University

Bologna, Italy

RECRUITING

University of Brescia

Brescia, Italy

RECRUITING

Università degli Studi di Napoli "Federico II"

Naples, Italy

RECRUITING

University of Barcelona

Barcelona, Spain

RECRUITING

Related Publications (6)

  • 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: 23400611RESULT

  • 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: 8885774RESULT

  • 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: 20576253RESULT

  • 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: 25644964RESULT

  • 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: 25637840RESULT

  • 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.

    PMID: 28067007RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Amanda Roman, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Roman, MD

CONTACT

215.955.9200amanda.roman@jefferson.edu

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

November 8, 2017

First Posted

November 13, 2017

Study Start

June 22, 2017

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

April 27, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

IT(3)US(3)EG(1)ES(1)