AzTrials
AzTrials

Cervical IncompetenceCOSANCT05268640

Cervical Occlusion Double-level Stitch Application

A study testing Double-level cervical cerclage and Single-level cervical cerclage in people with Cervical Incompetence, run by Centre of Postgraduate Medical Education at 7 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Cervical Incompetence
What is being tested?
Double-level cervical cerclage and Single-level cervical cerclage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
7 sitesPoland
Study dates
11 Mar 2022to 10 Mar 2025
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Poland7 sites

  • Department of Obstetrics, Women's Diseases and Oncological Gynecology, Nicolaus Copernicus University

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Department of Obstetrics and Gynecology, Oncological Gynecology and Gynecological Endocrinology, Medical University of Gdansk

    Gdansk, Pomeranian Voivodeship, 80-952

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, Łódź Voivodeship, 93-338

  • 1st Department of Obstetrics and Gynecology, Center of Postagraduate Medical Education

    Warsaw, Masovian Voivodeship, 01-004

  • Department of Obstetrics, Perinatology and Neonatology, Center of Postagraduate Medical Education

    Warsaw, Masovian Voivodeship, 01-809

  • 1st Department of Obstetrics and Gynecology, Medical University of Warsaw

    Warsaw, Masovian Voivodeship, 02-015

  • Institute of Mother and Child

    Warsaw

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Double-level cervical cerclage, Single-level cervical cerclage
Keywords
pregnancy, premature birth, cervix, pregnancy complication
Medical subject headings
Uterine Cervical Incompetence, Premature Birth, Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double-level cervical cerclageProcedure or surgery

    two cervical sutures + regimen of antibiotics + indomethacin + progesterone

  • Single-level cervical cerclageProcedure or surgery

    single cervical suture + regimen of antibiotics + indomethacin + progesterone

Study groups in NCT05268640
Study groupRoleWhat they receive
Double-level cerclageExperimentaldouble-level cervical cerclage placement with one suture above the other approximately 1 cm higher. Suture will be placed analogous to McDonald technique
Receives: Procedure: Double-level cervical cerclage
Single-level cerclageActive comparatorsingle-level cervical cerclage of McDonald technique
Receives: Procedure: Single-level cervical cerclage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. deliveries below 34+0 weeks of gestation

    number and rate of deliveries below 34+0 weeks of gestation

    Measured: observation after intervention for 26 weeks of until birth

Secondary outcomes (7)

  1. gestational age at delivery

    duration of pregnancy untill delivery in weeks and days

    Measured: observation after intervention for 26 weeks of until birth

  2. time from cerclage administration to delivery

    time from cerclage administration to delivery in days

    Measured: observation after intervention for 26 weeks of until birth

  3. fetal demise

    number and rate of pregnancies complicated by fetal demise

    Measured: observation after intervention for 26 weeks of until birth

  4. neonatal outcomes

    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

    Measured: observation after intervention for 26 weeks of until birth

  5. birth weight

    neonatal weight at delivery in grams

    Measured: observation after intervention for 26 weeks of until birth

  6. 5th minute Apgar score

    neonatal general condition at 5th minute after delivery according to the Apgar Scale

    Measured: observation after intervention for 26 weeks of until birth

  7. maternal outcomes

    maternal mortality, miscarriage, intrauterine infection, prelabour rupture of membranes, o cervical laceration

    Measured: observation after intervention for 26 weeks of until birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start11 Mar 2022
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05268640
Sponsor's protocol ID
nr 1/2022
Acronym
COSA
Status last verified
Sep 2025
First submitted
19 Jan 2022
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD share with other researchers will include all IPD that underlie results in a publication

Publications

  • Daskalakis G, Papantoniou N, Mesogitis S, Antsaklis A. Management of cervical insufficiency and bulging fetal membranes. Obstet Gynecol. 2006 Feb;107(2 Pt 1):221-6. doi: 10.1097/01.AOG.0000187896.04535.e6.

    PubMed 16449104

  • Stupin JH, David M, Siedentopf JP, Dudenhausen JW. Emergency cerclage versus bed rest for amniotic sac prolapse before 27 gestational weeks. A retrospective, comparative study of 161 women. Eur J Obstet Gynecol Reprod Biol. 2008 Jul;139(1):32-7. doi: 10.1016/j.ejogrb.2007.11.009. Epub 2008 Feb 20.

    PubMed 18243484

  • Althuisius SM, Dekker GA, Hummel P, van Geijn HP; Cervical incompetence prevention randomized cerclage trial. Cervical incompetence prevention randomized cerclage trial: emergency cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol. 2003 Oct;189(4):907-10. doi: 10.1067/s0002-9378(03)00718-x.

    PubMed 14586323

  • Oh KJ, Romero R, Park JY, Lee J, Conde-Agudelo A, Hong JS, Yoon BH. Evidence that antibiotic administration is effective in the treatment of a subset of patients with intra-amniotic infection/inflammation presenting with cervical insufficiency. Am J Obstet Gynecol. 2019 Aug;221(2):140.e1-140.e18. doi: 10.1016/j.ajog.2019.03.017. Epub 2019 Mar 28.

    PubMed 30928565

  • Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-1316. doi: 10.1097/AOG.0000000000000228.

    PubMed 24807330

  • Wood SL, Owen J. Cerclage: Shirodkar, McDonald, and Modifications. Clin Obstet Gynecol. 2016 Jun;59(2):302-10. doi: 10.1097/GRF.0000000000000190.

    PubMed 26974218

  • Park JM, Tuuli MG, Wong M, Carbone JF, Ismail M, Macones GA, Odibo AO. Cervical cerclage: one stitch or two? Am J Perinatol. 2012 Jun;29(6):477-81. doi: 10.1055/s-0032-1304831. Epub 2012 Mar 7.

    PubMed 22399222

  • Giraldo-Isaza MA, Fried GP, Hegarty SE, Suescum-Diaz MA, Cohen AW, Berghella V. Comparison of 2 stitches vs 1 stitch for transvaginal cervical cerclage for preterm birth prevention. Am J Obstet Gynecol. 2013 Mar;208(3):209.e1-9. doi: 10.1016/j.ajog.2012.11.039. Epub 2012 Nov 28.

    PubMed 23201330

  • Woensdregt K, Norwitz ER, Cackovic M, Paidas MJ, Illuzzi JL. Effect of 2 stitches vs 1 stitch on the prevention of preterm birth in women with singleton pregnancies who undergo cervical cerclage. Am J Obstet Gynecol. 2008 Apr;198(4):396.e1-7. doi: 10.1016/j.ajog.2007.10.782. Epub 2008 Feb 21.

    PubMed 18177834

  • Kosinska Kaczynska K, Rebizant B, Bednarek K, Dabrowski FA, Kajdy A, Muzyka-Placzynska K, Filipecka-Tyczka D, Uzar P, Kwiatkowski S, Torbe A, Grzesiak M, Kaczmarek P, Zyla M, Brawura-Biskupski-Samaha R. Emergency cerclage using double-level versus single-level suture in the management of cervical insufficiency (Cervical Occlusion double-level Stitch Application, COSA): study protocol for a multicentre, non-blinded, randomised controlled trial. BMJ Open. 2023 Jun 7;13(6):e071564. doi: 10.1136/bmjopen-2023-071564.

    PubMed 37286317

Questions about this trial

What is this clinical trial studying?

A study testing Double-level cervical cerclage and Single-level cervical cerclage in people with Cervical Incompetence, run by Centre of Postgraduate Medical Education at 7 sites in Poland.

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 16 inclusion and 0 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 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Poland. 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?

deliveries below 34+0 weeks of gestation (time frame: observation after intervention for 26 weeks of until birth). 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 NCT05268640, which also lists 10 linked publications.

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 30 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in