Clinical Trial

The Association of Pessary with Progesterone

Study Description

Canadian Study on the Association of Pessary With Progesterone

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Prometrium

Intravaginal use, off label, of Prometrium

Device - Dr. Arabin, cerclage pessary perforated

A Dr. Arabin, cerclage pessary perforated will be inserted participants diagnosed with a short cervix

Additional Information

Official Study Title

Canadian Study on the Association of Pessary With Progesterone

Clinical Trial ID

NCT03227705

ParticipAid ID

Xe0kXd