NCT03311867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

October 2, 2017

Last Update Submit

March 11, 2020

Conditions

Cervical Incompetence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Rate of preterm birth

    Delivery between 24-26 weeks gestation

Study Arms (2)

Braided Suture

ACTIVE COMPARATOR

Patient in this group will have a cerclage with ethibond suture material

Other: Ethibond Suture

Non- Braided Suture

ACTIVE COMPARATOR

Patient in this group will have a cerclage with prolene suture material

Other: Prolene Suture

Interventions

Ethibond SutureOTHER

Cerclage placement with ethibond

Braided Suture
Prolene SutureOTHER

Cerclage placement with prolene

Non- Braided Suture

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Maternal Fetal Medicine

New Brunswick, New Jersey, 08901, United States

Location

High Risk Obstetrics Clinic

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • Jayakumaran J, Angras K, Wang B, Paglia MJ, Rosen T, Schuster M. Monofilament vs multifilament suture for cervical cerclage: a multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Feb;5(2):100823. doi: 10.1016/j.ajogmf.2022.100823. Epub 2022 Dec 2. No abstract available.

    PMID: 36464242DERIVED

MeSH Terms

Conditions

Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAbortion, HabitualAbortion, SpontaneousPregnancy ComplicationsGenital Diseases

Study Officials

  • Meike Schuster, MD

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 17, 2017

Study Start

August 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)