Last reviewed · How we verify

NCT03311867: PECC

Prolene Versus Ethibond for Cervical Cerclage

Completed NA Last updated 13 March 2020
What this trial tests

NA trial testing Ethibond Suture in Cervical Incompetence in 16 participants. Completed in 31 December 2019.

Timeline
1 August 2017
Primary endpoint
31 December 2019
31 December 2019

Quick facts

Lead sponsorRutgers University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment16
Start date1 August 2017
Primary completion31 December 2019
Estimated completion31 December 2019
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rutgers University

Who can join

18 and older, female only, with Cervical Incompetence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Rutgers University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03311867.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing