Canadian Study on the Association of Pessary With Progesterone
Status:
Unknown status
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
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 around the cervix) versus "no pessary" in patients with a short cervix showed a
4-fold reduction in the rate of spontaneous prematurity <34 weeks of gestation and a
reduction in perinatal morbidity and mortality. This result was not found in a subsequent RCT
and another study on the subject had to be stopped in the face of slow recruitment.
Currently, the obstetric scientific community believes that other RCTs are needed before
using the pessary in the clinic as a therapeutic option to prevent prematurity in the
presence of a short cervix. However, before starting a large RCT, it is important to test the
feasibility of recruitment.
Phase:
N/A
Details
Lead Sponsor:
Université de Sherbrooke
Collaborators:
Centre hospitalier de l'Université de Montréal (CHUM) CHU de Quebec-Universite Laval Jewish General Hospital Kingston General Hospital Kingston Health Sciences Centre St. Justine's Hospital The Ottawa Hospital