Status:
COMPLETED
Cervical Occlusion Double-level Stitch Application
Lead Sponsor:
Centre of Postgraduate Medical Education
Collaborating Sponsors:
Polish Mother Memorial Hospital Research Institute
Medical University of Warsaw
Conditions:
Cervical Incompetence
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 contra...
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 vag...
Eligibility Criteria
Inclusion
- 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 - any of the following occuring before the administration of the cerclage:
- 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.
Exclusion
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05268640
Start Date
March 11 2022
End Date
March 10 2025
Last Update
September 30 2025
Active Locations (7)
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1
Department of Obstetrics, Women's Diseases and Oncological Gynecology, Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
2
1st Department of Obstetrics and Gynecology, Center of Postagraduate Medical Education
Warsaw, Masovian Voivodeship, Poland, 01-004
3
Department of Obstetrics, Perinatology and Neonatology, Center of Postagraduate Medical Education
Warsaw, Masovian Voivodeship, Poland, 01-809
4
1st Department of Obstetrics and Gynecology, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 02-015