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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Cerclage placement with ethibond
Cerclage placement with prolene
Division of Maternal Fetal Medicine
New Brunswick, New Jersey, United States
High Risk Obstetrics Clinic
New Brunswick, New Jersey, United States
Change in Vaginal Microbiome
16S rRNA gene sequencing will be performed
Time frame: 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
Time frame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Rate of preterm birth
The investigators will follow patients through their pregnancy and observe if suture material is related to increased preterm birth
Time frame: Delivery between 24-26 weeks gestation
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