Prolene Versus Ethibond for Cervical Cerclage

Study Overview
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Brief Summary
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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.

Official Title
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Prolene Versus Ethibond for Cervical Cerclage

Conditions
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Cervical Incompetence

Intervention / Treatment
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* Other: Ethibond Suture
* Other: Prolene Suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Braided Suture<br>Patient in this group will have a cerclage with ethibond suture material | Other: Ethibond Suture<br>* Cerclage placement with ethibond<br>|
| Active Comparator: Non- Braided Suture<br>Patient in this group will have a cerclage with prolene suture material | Other: Prolene Suture<br>* Cerclage placement with prolene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |