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Completed

NCT Number: NCT03311867

Prolene Versus Ethibond for Cervical Cerclage

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Maternal Fetal Medicine, New Brunswick, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • younger than 18 years of age
  • multiple gestation
  • iatrogenic preterm delivery
  • pregnancies with fetal anomalies

Treatment and study plan

Ethibond Suture

Other

Cerclage placement with ethibond

Prolene Suture

Other

Cerclage placement with prolene

Primary outcomes

  1. Change in Vaginal Microbiome

    Time frame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)

    16S rRNA gene sequencing will be performed

  2. Change in Vaginal Cytokine Expression

    Time frame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)

    Cytokine analysis will be performed

Secondary outcomes

  1. Rate of preterm birth

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rutgers University

Other

Registry information

Acronym: PECC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2017
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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