Cervical Occlusion Double-level Stitch Application

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

Interventions

PROCEDURE

Double-level cervical cerclage

two cervical sutures + regimen of antibiotics + indomethacin + progesterone

PROCEDURE

Single-level cervical cerclage

single cervical suture + regimen of antibiotics + indomethacin + progesterone

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute

  collaborator OTHER

• Medical University of Warsaw

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Institute of Mother and Child, Warsaw, Poland

  collaborator OTHER

• Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

  collaborator OTHER

• Centre of Postgraduate Medical Education

  lead OTHER

Principal Investigators

• Katarzyna Kosinska Kaczynska, Prof. · Center of Postgraduate Medical Education

• Anna Kajdy, MD PhD · Center of Postgraduate Medical Education

• Mariusz Grzesiak, Prof. · Polish Mother's Memorial Hospital - Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-11

Primary Completion

2025-03-10

Completion

2025-03-10

Countries

• Poland

Study Locations