Cervical Occlusion Double-level Stitch Application

NCT05268640 | Completed DMC

• 1 other identifier: nr 1/2022
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 7

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.

Conditions

Cervical Incompetence

Keywords

pregnancy; premature birth; cervix; pregnancy complication

Outcome Measures

Primary Outcomes (1)

• deliveries below 34+0 weeks of gestation

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

  observation after intervention for 26 weeks of until birth

Secondary Outcomes (7)

• gestational age at delivery

  observation after intervention for 26 weeks of until birth

• time from cerclage administration to delivery

  observation after intervention for 26 weeks of until birth

• fetal demise

  observation after intervention for 26 weeks of until birth

• neonatal outcomes

  observation after intervention for 26 weeks of until birth

• birth weight

  observation after intervention for 26 weeks of until birth

Other Outcomes (1)

• cerclage procedure complications occurring within 48 hours after cerclage placement

  observation after intervention for 48 hours

Study Arms (2)

Double-level cerclage

EXPERIMENTAL

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

Single-level cerclage

ACTIVE COMPARATOR

single-level cervical cerclage of McDonald technique

Procedure: Single-level cervical cerclage

Interventions

Double-level cervical cerclage PROCEDURE

two cervical sutures + regimen of antibiotics + indomethacin + progesterone

Double-level cerclage

Single-level cervical cerclage PROCEDURE

single cervical suture + regimen of antibiotics + indomethacin + progesterone

Single-level cerclage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female - pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead
• Polish Mother Memorial Hospital Research Institute: collaborator
• Medical University of Warsaw: collaborator
• Medical University of Gdansk: collaborator
• Institute of Mother and Child, Warsaw, Poland: collaborator
• Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz: collaborator

Study Sites (7)

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

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

Warsaw, Masovian Voivodeship, 01-004, Poland

Location

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

Warsaw, Masovian Voivodeship, 01-809, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-015, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Institute of Mother and Child

Warsaw, Poland

Location

Polish Mother's Memorial Hospital - Research Institute

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Related Publications (10)

• 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.

  PMID: 16449104 RESULT

• 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.

  PMID: 18243484 RESULT

• 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.

  PMID: 14586323 RESULT

• 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.

  PMID: 30928565 RESULT

• 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.

  PMID: 24807330 RESULT

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

  PMID: 26974218 RESULT

• 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.

  PMID: 22399222 RESULT

• 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.

  PMID: 23201330 RESULT

• 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.

  PMID: 18177834 RESULT

• 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.

  PMID: 37286317 DERIVED

MeSH Terms

Conditions

Uterine Cervical Incompetence; Premature Birth; Pregnancy Complications

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: March 7, 2022
• Study Start: March 11, 2022
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available after completing of recruitment and will be available for 12 months
• Access Criteria: Data will be available od request sent to the principal researchers. All requests for information will be reviewed by the Study Officials.

Locations

PL (7)