Prolene Versus Ethibond for Cervical Cerclage

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03311867

Acronym

PECC

Enrollment

Registered

2017-10-17

Start date

2017-08-01

Completion date

2019-12-31

Last updated

2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Incompetence

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.

Interventions

OTHEREthibond Suture

Cerclage placement with ethibond

OTHERProlene Suture

Cerclage placement with prolene

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Rate of preterm birth	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026