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
Phase: NA
Conditions: Cervical Incompetence
Sponsor: Centre of Postgraduate Medical Education

   
 
Klinika Położnictwa, Perinatologii i Neonatologii CMKP 
SPZOZ - Szpital Bielański im. ks. Jerzego Popiełuszki 
01-809 Warszawa, ul. Cegłowska 80 
tel. +48 (22) 56 – 90 - 274 
Kierownik Kliniki: dr hab. n. med. Katarzyna Kosińska-Kaczyńska, prof. CMKP 
 
 
1.03.2022 
 
Comparison of the Efficacy of Emergency Two-level and Single Cervical Cerclage in 
Cervical Insufficiency in the Second Trimester of Pregnancy - Multicenter Prospective 
Randomized Trial 
Cervical Occlusion Two-level Stitch Application (COSA) 
 
Study Protocol and Statistical Analysis Plan 
Unique Protocol ID: nr 5/2024 
 
 
This is an open-label, multicentre, prospective, randomised controlled trial (RCT). 
Women 
diagnosed with cervical insufficiency with fetal membranes visible through open internal os 
between 
16+0 and 25+6 weeks of gestation will be included to the study. The inclusion criteria consist 
of 
singleton pregnancy, gestational age 16+0 to 25+6 weeks, live fetus. The exclusion criteria are: 
• preterm rupture of membranes, 
• vaginal bleeding, 
• regular uterine contractions, 
• maternal fever, 
• diagnosed fetal genetic disorders, 
• diagnosed major fetal anomalies, 
• multiple pregnancy, 
• congenital uterine anomalies, 
• fetal demice, 
• maternal leukocyte count >20 million/microliter, 
• maternal serum C-reactive protein concentration > 20 mg/L. 
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). 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 
ingle-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 above the other approximately 1 
cm 
higher. After randomization in the operating theater under regional anesthesia, after vaginal 
disinfection and visualization of the cervix, McDonald cerclage will be administered. In case 
of fetal membranes bulging to the vagina the patient will be placed in the Trendelenburg 
position with filling the bladder with saline and / or amnioreduction. In double-level cerclage 
arm two separate sutures analogous to the McDonald technique will be places, one 
approximately 1 cm higher above the other. 
After the operation patients will receive standard perinatal care and will be followed up until 
miscarriage or delivery. The time and mode of delivery, the occurrence of complications related 
to the 
cerclage placement and neonatal outcomes will be analyzed. 
In the only randomized trial evaluating the effectiveness of rescue sutures in comparison to 
conservative management and bed rest, the rate of deliveries before 34 weeks of gestation was 
53%. 
Assuming a reduction of deliveries before 34 weeks to 20%, based on the power analysis of the 
test, the 
size of each group was calculated for 39 patients. 
After ending recruitment and collection of data, statistical analysis will be performed. Variables 
will be described as median, interquartile range or number and percentage. The Mann–Whitney 
test and the Fisher’s exact test will be used for the statistical analysis. p-values < 0.05 will be 
considered significant.