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Prolene Versus Ethibond for Cervical Cerclage (PECC)

Primary Purpose

Cervical Incompetence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ethibond Suture
Prolene Suture
Sponsored by
Rutgers University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cervical Incompetence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Maternal Fetal Medicine
  • High Risk Obstetrics Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Braided Suture

Non- Braided Suture

Arm Description

Patient in this group will have a cerclage with ethibond suture material

Patient in this group will have a cerclage with prolene suture material

Outcomes

Primary Outcome Measures

Change in Vaginal Microbiome
16S rRNA gene sequencing will be performed
Change in Vaginal Cytokine Expression
Cytokine analysis will be performed

Secondary Outcome Measures

Rate of preterm birth
The investigators will follow patients through their pregnancy and observe if suture material is related to increased preterm birth

Full Information

First Posted
October 2, 2017
Last Updated
March 11, 2020
Sponsor
Rutgers University
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1. Study Identification

Unique Protocol Identification Number
NCT03311867
Brief Title
Prolene Versus Ethibond for Cervical Cerclage
Acronym
PECC
Official Title
Prolene Versus Ethibond for Cervical Cerclage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Incompetence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Braided Suture
Arm Type
Active Comparator
Arm Description
Patient in this group will have a cerclage with ethibond suture material
Arm Title
Non- Braided Suture
Arm Type
Active Comparator
Arm Description
Patient in this group will have a cerclage with prolene suture material
Intervention Type
Other
Intervention Name(s)
Ethibond Suture
Intervention Description
Cerclage placement with ethibond
Intervention Type
Other
Intervention Name(s)
Prolene Suture
Intervention Description
Cerclage placement with prolene
Primary Outcome Measure Information:
Title
Change in Vaginal Microbiome
Description
16S rRNA gene sequencing will be performed
Time Frame
At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Title
Change in Vaginal Cytokine Expression
Description
Cytokine analysis will be performed
Time Frame
At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Secondary Outcome Measure Information:
Title
Rate of preterm birth
Description
The investigators will follow patients through their pregnancy and observe if suture material is related to increased preterm birth
Time Frame
Delivery between 24-26 weeks gestation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meike Schuster, MD
Organizational Affiliation
Rutgers Robert Wood Johnson Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Maternal Fetal Medicine
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
High Risk Obstetrics Clinic
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Prolene Versus Ethibond for Cervical Cerclage

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