Canadian Study on the Association of Pessary With Progesterone

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 prævia - cerclage of the cervix in place - antecedent of conisation - multiple gestation - allergy/intolerance or hypersensitivity to progesterone or any of its ingredients.