Cervical Occlusion Double-level Stitch Application

NCT ID: NCT05268640

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-11
• Study Completion Date: 2025-03-10

Brief 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 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.

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.

Conditions

Cervical Incompetence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Double-level cervical cerclage

Intervention Type: PROCEDURE

two cervical sutures + regimen of antibiotics + indomethacin + progesterone

Single-level cerclage

single-level cervical cerclage of McDonald technique

Group Type: ACTIVE_COMPARATOR

Single-level cervical cerclage

Intervention Type: PROCEDURE

single cervical suture + regimen of antibiotics + indomethacin + progesterone

Interventions

Double-level cervical cerclage

two cervical sutures + regimen of antibiotics + indomethacin + progesterone

Intervention Type: PROCEDURE

Single-level cervical cerclage

single cervical suture + regimen of antibiotics + indomethacin + progesterone

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: collaborator

Medical University of Gdansk

OTHER

Sponsor Role: collaborator

Institute of Mother and Child, Warsaw, Poland

OTHER

Sponsor Role: collaborator

Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

OTHER

Sponsor Role: collaborator

Centre of Postgraduate Medical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katarzyna Kosinska Kaczynska, Prof.

Role: PRINCIPAL_INVESTIGATOR

Center of Postgraduate Medical Education

Anna Kajdy, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Center of Postgraduate Medical Education

Mariusz Grzesiak, Prof.

Role: PRINCIPAL_INVESTIGATOR

Polish Mother's Memorial Hospital - Research Institute

Locations

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Institute of Mother and Child

Warsaw, , Poland

Polish Mother's Memorial Hospital - Research Institute

Lodz, Łódź Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: RESULT

PMID: 16449104 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18243484 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14586323 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30928565 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24807330 (View on PubMed)

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

Reference Type: RESULT

PMID: 26974218 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22399222 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23201330 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18177834 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37286317 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

nr 1/2022

Identifier Type: -

Identifier Source: org_study_id