Prolene Versus Ethibond for Cervical Cerclage (PECC)

March 11, 2020 updated by: Meike Schuster, Rutgers University
The purpose of the proposed study is to examine the relationship between cerclage suture material of Ethibond and Prolene and its effect on the vaginal microbiome in a prospective randomized control trial. Ethibond is another commonly used suture material for performing cervical cerclage that shares some characteristics with previously studied suture materials. It is braided like the Mersilene, but thinner like the monofilament Prolene. The investigators will study whether Ethibond causes the vaginal microbiome to be adversely affected like Mersilene or whether there is a healthy microbiome like Prolene. This study will allow the investigators to determine whether it is advisable to continue to use Ethibond for cervical cerclage in clinical practice, or whether obstetricians should avoid its use as now done with Mersilene.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Division of Maternal Fetal Medicine
      • New Brunswick, New Jersey, United States, 08901
        • High Risk Obstetrics Clinic

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Greater than18 years of age
  • Singleton pregnancy
  • History of preterm delivery between 17 0/7 weeks - 33 4/7 weeks with painless cervical

dilation or cervical insufficiency

Exclusion Criteria:

  • younger than 18 years of age
  • multiple gestation
  • iatrogenic preterm delivery
  • pregnancies with fetal anomalies

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Braided Suture
Patient in this group will have a cerclage with ethibond suture material
Other: Ethibond Suture
Cerclage placement with ethibond
Active Comparator: Non- Braided Suture
Patient in this group will have a cerclage with prolene suture material
Other: Prolene Suture
Cerclage placement with prolene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vaginal Microbiome
Time Frame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
16S rRNA gene sequencing will be performed
At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Change in Vaginal Cytokine Expression
Time Frame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Cytokine analysis will be performed
At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of preterm birth
Time Frame: Delivery between 24-26 weeks gestation
The investigators will follow patients through their pregnancy and observe if suture material is related to increased preterm birth
Delivery between 24-26 weeks gestation

Collaborators and Investigators

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

Sponsor

Rutgers University

Investigators

  • Principal Investigator: Meike Schuster, MD, Rutgers Robert Wood Johnson Medical School

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)

August 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PECC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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