Canadian Study on the Association of Pessary With Progesterone

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.

Conditions

• Preterm Birth
• Short Cervix

Interventions

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• CHU de Quebec-Universite Laval

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• Jewish General Hospital

  collaborator OTHER

• The Ottawa Hospital

  collaborator OTHER

• Queen's University

  collaborator OTHER

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Jean-Charles Pasquier, MD, PhD · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-06-04

Primary Completion

2022-10-06

Completion

2022-10-06

Countries

• Canada

Study Locations