Prolene Versus Ethibond for Cervical Cerclage
- Conditions
- Cervical Incompetence
- Interventions
- Other: Ethibond SutureOther: Prolene Suture
- Registration Number
- NCT03311867
- Lead Sponsor
- Rutgers University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
- 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
- younger than 18 years of age
- multiple gestation
- iatrogenic preterm delivery
- pregnancies with fetal anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Braided Suture Ethibond Suture Patient in this group will have a cerclage with ethibond suture material Non- Braided Suture Prolene Suture Patient in this group will have a cerclage with prolene suture material
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Division of Maternal Fetal Medicine
🇺🇸New Brunswick, New Jersey, United States
High Risk Obstetrics Clinic
🇺🇸New Brunswick, New Jersey, United States