Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 7 for:    twins cerclage

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03340688
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Federico II University
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Layout table for study information
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

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



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


Secondary Outcome Measures :
  1. Spontaneous preterm birth rates [ Time Frame: at delivery ]
    Incidence of spontaneous preterm birth less than 34 weeks

  2. 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

  3. Mean gestational age at delivery [ Time Frame: at delivery ]
    Mean value of gestational age at delivery (weeks)

  4. Birth weight at birth [ Time Frame: at delivery ]
    Mean value (grams)

  5. Gestational age at spontaneous rupture of membranes [ Time Frame: at delivery ]
    Mean value (weeks) through study completion

  6. Premature rupture of membranes [ Time Frame: at delivery ]
    Incidence

  7. Chorioamnionitis [ Time Frame: at delivery ]
    Incidence

  8. 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

  9. Neonatal death [ Time Frame: Between birth and 28 days of age ]
    Incidence

  10. Maternal death [ Time Frame: Between birth and 6 weeks postpartum ]
    Incidence

  11. Interval between diagnosis and delivery [ Time Frame: at delivery ]
    Mean value (days) through study completion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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:

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

Exclusion Criteria:

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

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
Layout table for location contacts
Contact: Amanda Roman, MD 215.955.9200 amanda.roman@jefferson.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Amanda Roman, MD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:
Informed Consent Form  [PDF] June 22, 2017

Publications of Results:

Layout table for additonal information
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)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications