Prolene Versus Ethibond for Cervical Cerclage
Completed · Not applicable
Conditions studied: Cervical Incompetence
In brief
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.
Key facts
- Study ID
- NCT03311867
- Run by
- Rutgers University
- People needed
- 16
- Starts
- 2017-08-01
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2020-03-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- younger than 18 years of age
- multiple gestation
- iatrogenic preterm delivery
- pregnancies with fetal anomalies
Where it is running
- Division of Maternal Fetal Medicine — New Brunswick, New Jersey, United States
- High Risk Obstetrics Clinic — New Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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