Status:
COMPLETED
Canadian Study on the Association of Pessary With Progesterone
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Centre hospitalier de l'Université de Montréal (CHUM)
CHU de Quebec-Universite Laval
Conditions:
Preterm Birth
Short Cervix
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Prematurity is the leading cause of neonatal morbidity causing more than 1 million deaths worldwide per year. In 2012, a randomized controlled trial (RCT) testing "pessary" (silicone ring placed aroun...
Detailed Description
Hypothesis: A standardized recruitment process could allow the inclusion of 0.9% patient (CI 95%: 0,78-1.04) among women receiving a 18-23 weeks ultrasound scan. Recruitment: Participants will be rec...
Eligibility Criteria
Inclusion
- patient with a short cervix equal to or less than 25 mm by transvaginal ultrasound
- gestational age between 18 (0/7) and 23 (6/7) weeks of gestation according to the results of the ultrasound of the first trimester, or by integrating the date of the last period
- patients who were informed of the study and agreed to sign the consent form.
Exclusion
- pregnancy with a fetus with a major congenital malformation - regular and painful uterine activity - history of preterm premature rupture of membranes (PPROM) - active vaginal bleeding - complete and incomplete placenta previa - cerclage of the cervix in place - antecedent of conisation - multiple gestation - ballooning of membranes outside the cervix into the vagina - allergy/intolerance or hypersensitivity to progesterone or any of its ingredients - chronic medical conditions that would interfere with study participation or evaluation of treatment - vaginal administration of another drug.
Key Trial Info
Start Date :
June 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03227705
Start Date
June 4 2018
End Date
October 6 2022
Last Update
April 6 2023
Active Locations (8)
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1
Kingston General Hospital
Kingston, Ontario, Canada
2
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
3
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0C1
4
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5