NCT03311867

Prolene Versus Ethibond for Cervical Cerclage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Rutgers University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Incompetence

Interventions

Type	Name	Description
OTHER	Ethibond Suture	Cerclage placement with ethibond
OTHER	Prolene Suture	Cerclage placement with prolene

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-10-17
• Last updated: 2020-03-13

Locations

2 sites across 1 country: United States