Cervical IncompetencePECCNCT03311867
Prolene Versus Ethibond for Cervical Cerclage
A study testing Ethibond Suture and Prolene Suture in people with Cervical Incompetence, run by Rutgers University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Incompetence
- What is being tested?
- Ethibond Suture and Prolene Suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- younger than 18 years of age
- multiple gestation
- iatrogenic preterm delivery
- pregnancies with fetal anomalies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division of Maternal Fetal Medicine
New Brunswick, New Jersey, 08901
High Risk Obstetrics Clinic
New Brunswick, New Jersey, 08901
About this study
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.
- Conditions
- Cervical Incompetence
- Being tested
- Ethibond Suture, Prolene Suture
- Medical subject headings
- Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethibond SutureOther
Cerclage placement with ethibond
Prolene SutureOther
Cerclage placement with prolene
| Study group | Role | What they receive |
|---|---|---|
| Braided Suture | Active comparator | Patient in this group will have a cerclage with ethibond suture material Receives: Other: Ethibond Suture |
| Non- Braided Suture | Active comparator | Patient in this group will have a cerclage with prolene suture material Receives: Other: Prolene Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Microbiome
16S rRNA gene sequencing will be performed
Measured: 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
Measured: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Secondary outcomes (1)
Rate of preterm birth
The investigators will follow patients through their pregnancy and observe if suture material is related to increased preterm birth
Measured: Delivery between 24-26 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical IncompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meike Schuster, Rutgers University
- Investigators
- Meike Schuster, MD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311867
- Sponsor's protocol ID
- PECC
- Acronym
- PECC
- Status last verified
- Mar 2020
- First submitted
- 2 Oct 2017
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36464242
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolene Versus Ethibond for Cervical Cerclage
- ClinicalTrials.gov ID
- NCT03311867
- Acronym / sponsor ID
- PECC / PECC
- Conditions
- Cervical Incompetence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Braided Suture | Active comparator | Other: Ethibond SuturePatient in this group will have a cerclage with ethibond suture material |
| Non- Braided Suture | Active comparator | Other: Prolene SuturePatient in this group will have a cerclage with prolene suture material |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- younger than 18 years of age
- multiple gestation
- iatrogenic preterm delivery
- pregnancies with fetal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethibond SutureCerclage placement with ethibond | Other | Braided Suture |
| Prolene SutureCerclage placement with prolene | Other | Non- Braided Suture |
Primary outcome
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
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
1 secondary outcome
Rate of preterm birth
Time frame: Delivery between 24-26 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Derived from this study: PubMed 36464242Jayakumaran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meike Schuster, MD principal investigator
Rutgers Robert Wood Johnson Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethibond Suture and Prolene Suture in people with Cervical Incompetence, run by Rutgers University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaginal Microbiome (time frame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.