Prolene Versus Ethibond for Cervical Cerclage

Cervical Incompetence Clinical Trial

— PECC  

Official title:

Prolene Versus Ethibond for Cervical Cerclage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311867
• Other study ID #: PECC
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Rutgers University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Incompetence
• Uterine Cervical Incompetence

Intervention

Other:
• Ethibond Suture
Cerclage placement with ethibond
• Prolene Suture
Cerclage placement with prolene

Locations

Country	Name	City	State
United States	Division of Maternal Fetal Medicine	New Brunswick	New Jersey
United States	High Risk Obstetrics Clinic	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vaginal Microbiome	16S rRNA gene sequencing will be performed	At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Primary	Change in Vaginal Cytokine Expression	Cytokine analysis will be performed	At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Secondary	Rate of preterm birth	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