Physical Exam Indicated Cerclage in Twin Gestations (TWIN-PEIC)

April 23, 2020 updated by: Thomas Jefferson University

Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Bologna University
      • Brescia, Italy
        • University of Brescia
      • Naples, Italy
        • Università degli Studi di Napoli "Federico II"
  • Poland
      • Warsaw, Poland
        • University of Warsaw
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Wright State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Texas
      • Austin, Texas, United States, 78758
        • Austin Maternal Fetal Medicine St David's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Physical exam indicated cerclage
Cerclage
Procedure: Physical exam indicated cerclage
Cervical cerclage
No Intervention: Expectant management
No cerclage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preterm delivery less than 34 weeks
Time Frame: at delivery
Incidence of preterm birth less than 34 weeks (any indication)
at delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at delivery
Mean gestational age at delivery
Time Frame: at delivery
Mean value of gestational age at delivery (weeks)
at delivery
Birth weight at birth
Time Frame: at delivery
Mean value (grams)
at delivery
Spontaneous preterm birth less than 34
Time Frame: at delivery
Incidence of spontaneous preterm birth less than 34 weeks
at delivery
Gestational age at spontaneous rupture of membranes
Time Frame: at presentation of rupture membranes
Mean value (weeks) through study completion
at presentation of rupture membranes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Incidence between birth and 28 days of age
Maternal death
Time Frame: Between birth and 6 weeks postpartum
Incidence
Between birth and 6 weeks postpartum
Interval between diagnosis and delivery
Time Frame: at delivery
Mean value (days) through study completion
at delivery
Chorioamnionitis
Time Frame: Time of delivery
Incidence
Time of delivery
Fetal demise
Time Frame: Incidence before delivery
Incidence
Incidence before delivery
Neonatal death
Time Frame: Incidence between birth and 28 days of age
Incidence
Incidence between birth and 28 days of age
Perinatal death
Time Frame: Incidence before and after birth ulntil 28 days of age
Incidence
Incidence before and after birth ulntil 28 days of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
University of Bologna
Columbia University
Federico II University
George Washington University
University of Rochester
Baystate Medical Center
Albany Medical College
Wright State University
Università degli Studi di Brescia
Maternal Fetal Medicine Associates
University of Warsaw

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda Roman, MD, amanda.roman@jefferson.edu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ThomasJeffersonU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De identified data

IPD Sharing Time Frame

June 2020 2 years

IPD Sharing Access Criteria

x

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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