Cervical Occlusion Double-level Stitch Application (COSA)

September 29, 2025 updated by: Centre of Postgraduate Medical Education

Comparison of the Efficacy of Emergency Double-level and Single Cervical Cerclage in Cervical Insufficiency in the Second Trimester of Pregnancy - Multicenter Prospective Randomized Trial

Cervical insufficiency is defined as painless dilatation of the cervix during the second trimester of pregnancy. As a result of shortening and opening of the cervix, despite the lack of uterine contractions, the fetal membranes invade into the cervical canal and then into the vagina, which results in premature rupture of the membranes and miscarriage or preterm delivery. Cervical insufficiency occurs in approximately 1% of the women. The aim of the study is to evaluate the effectiveness of placing a double-level cervical cerclage in the treatment of advanced cervical insufficiency. The hypothesis assumes that the insertion of a double-level suture is associated with a reduction in the rate of deliveries < 34 weeks of gestation in comparison to single-level suture. The study will include women with fetal membranes visible through open external os of the cervix between 16+0 and 25+6 weeks. They will be randomized to two arms - McDonald's single cervical cerclage or two-level cerclage.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, multicentre, prospective, randomised controlled trial (RCT). Women will be randomized to the single-level cerclage arm or the double-level cerclage. Each patient will have a vaginal swab for aerobic and anaerobic bacteria and fungi culture, as well as for mycoplasmas, chlamydia and ureaplasma performed. Each patient will be treated with progesterone (vaginally 2 x 100 mg per day) and empirical antibiotic therapy (ceftriaxone 2.0 g iv + clarithromycin 2 x 500 mg po + metronidazole 3 x 500 mg iv for 7 days). If specific pathogens will be detected, the antibiotic therapy will be modified according to the antibiogram. If the diagnosis of cervical insufficiency will be made >23 weeks of gestation a single course of corticosteroid therapy will be administered (betamethasone 2 x 12 mg im) if the rsik of delivery within 7 days will be assessed as high. Indomethacin will also be administered for 48 hours (starting the day of cerclage administration, indomethacin 2 x 75 mg po for 48 hours). In the single-level cerclage arm McDonald suture will be administered. In the double-level cerclage arm two separate sutures analogous to McDonald technique will be placed, one approximately 1 cm higher above the other. Patients will be followed up until miscarriage or delivery and will receive standard perinatal care. Gestational age at delivery, the occurrence of cerclage complications and neonatal outcomes will be analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland
        • Institute of Mother and Child
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Department of Obstetrics, Women's Diseases and Oncological Gynecology, Nicolaus Copernicus University
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-004
        • 1st Department of Obstetrics and Gynecology, Center of Postagraduate Medical Education
      • Warsaw, Masovian Voivodeship, Poland, 01-809
        • Department of Obstetrics, Perinatology and Neonatology, Center of Postagraduate Medical Education
      • Warsaw, Masovian Voivodeship, Poland, 02-015
        • 1st Department of Obstetrics and Gynecology, Medical University of Warsaw
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-952
        • Department of Obstetrics and Gynecology, Oncological Gynecology and Gynecological Endocrinology, Medical University of Gdansk
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-338
        • Polish Mother's Memorial Hospital - Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • singleton pregnancy,
  • gestational age 16+0 to 25+6 weeks,
  • live fetus,
  • cervical incompetence with fetal membranes visible through external os before 24+0 weeks of gestation,
  • informed written consent.

Exclusion Criteria - any of the following occuring before the administration of the cerclage:

  • preterm premature rupture of membranes,
  • vaginal bleeding,
  • active regular uterine contractions,
  • fetal demise,
  • fever,
  • intrauterine infection (diagnosed in case of maternal body temperature ≥ 38°C with no alternative cause identified and at least 2 symptoms among the following appear: fetal tachycardia > 160 bpm for 10 minutes or longer, uterine pain, purulent vaginal discharge, white blood cell count > 15 G/L in the absence of corticosteroid treatment or increased plasma C-reactive protein > 10 mg/L),
  • known genetic defects of the fetus,
  • known lethal fetal malformations,
  • congenital uterine defects,
  • multiple pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Double-level cerclage
double-level cervical cerclage placement with one suture above the other approximately 1 cm higher. Suture will be placed analogous to McDonald technique
Procedure: Double-level cervical cerclage
two cervical sutures + regimen of antibiotics + indomethacin + progesterone
Active Comparator: Single-level cerclage
single-level cervical cerclage of McDonald technique
Procedure: Single-level cervical cerclage
single cervical suture + regimen of antibiotics + indomethacin + progesterone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
deliveries below 34+0 weeks of gestation
Time Frame: observation after intervention for 26 weeks of until birth
number and rate of deliveries below 34+0 weeks of gestation
observation after intervention for 26 weeks of until birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
gestational age at delivery
Time Frame: observation after intervention for 26 weeks of until birth
duration of pregnancy untill delivery in weeks and days
observation after intervention for 26 weeks of until birth
time from cerclage administration to delivery
Time Frame: observation after intervention for 26 weeks of until birth
time from cerclage administration to delivery in days
observation after intervention for 26 weeks of until birth
fetal demise
Time Frame: observation after intervention for 26 weeks of until birth
number and rate of pregnancies complicated by fetal demise
observation after intervention for 26 weeks of until birth
neonatal outcomes
Time Frame: observation after intervention for 26 weeks of until birth
number and rate of: congenital infections, respiratory morbidity, hospitalizations in the Neonatal Intensive Care Unit, early neurodevelopmental morbidity, gastrointestinal morbidity, retinopathy of prematurity, newborn's death before the discharge home
observation after intervention for 26 weeks of until birth
birth weight
Time Frame: observation after intervention for 26 weeks of until birth
neonatal weight at delivery in grams
observation after intervention for 26 weeks of until birth
5th minute Apgar score
Time Frame: observation after intervention for 26 weeks of until birth
neonatal general condition at 5th minute after delivery according to the Apgar Scale
observation after intervention for 26 weeks of until birth
maternal outcomes
Time Frame: observation after intervention for 26 weeks of until birth
maternal mortality, miscarriage, intrauterine infection, prelabour rupture of membranes, o cervical laceration
observation after intervention for 26 weeks of until birth

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cerclage procedure complications occurring within 48 hours after cerclage placement
Time Frame: observation after intervention for 48 hours
excessive vaginal bleeding, intrauterine infection, prelabour rupture of membranes
observation after intervention for 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre of Postgraduate Medical Education

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Warsaw
Polish Mother Memorial Hospital Research Institute
Medical University of Gdansk
Institute of Mother and Child, Warsaw, Poland
Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katarzyna Kosinska Kaczynska, Prof., Center of Postgraduate Medical Education
  • Principal Investigator: Anna Kajdy, MD PhD, Center of Postgraduate Medical Education
  • Principal Investigator: Mariusz Grzesiak, Prof., Polish Mother's Memorial Hospital - Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • nr 1/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD share with other researchers will include all IPD that underlie results in a publication

IPD Sharing Time Frame

Data will become available after completing of recruitment and will be available for 12 months

IPD Sharing Access Criteria

Data will be available od request sent to the principal researchers. All requests for information will be reviewed by the Study Officials.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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