An interventional study of Ethibond Suture and Prolene Suture in Cervical Incompetence, sponsored by Rutgers University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by Rutgers University · Not applicable, Interventional, and Basic science
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.
37 studies on the registry are indexed under Uterine Cervical Incompetence; 11 are open to participants now.
This study's enrollment of 16 is below the median of 70 across 22 interventional studies indexed under Uterine Cervical Incompetence.
Browse Uterine Cervical Incompetence studies →Rutgers University is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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dilation or cervical insufficiency
Exclusion Criteria:
Patient in this group will have a cerclage with ethibond suture material
Other: Ethibond Suture
Patient in this group will have a cerclage with prolene suture material
Other: Prolene Suture
Cerclage placement with ethibond
Cerclage placement with prolene
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Uterine Cervical Incompetence →
Rutgers University