Canadian Study on the Association of Pessary With Progesterone
Condition: Preterm Birth; Short Cervix
MeSH terms: Premature Birth
Study type: Interventional

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.
    

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 recruited, in a three-step manner, among women appointing
      for the 18-23 weeks ultrasound scan; i) assessment of the cervical length by abdominal
      ultrasound, ii) an endovaginal ultrasound measurement will be performed if the cervical
      length is ≤ 30 mm, iii) enrollment and consent of the patient to the pilot study, under the
      confirmation of the presence of a short cervix (≤ 25 mm) by the endovaginal ultrasound.

      Intervention: Vaginal progesterone (200 mg/day, PROMETRIUM®, Merck Canada Inc.) until 37
      weeks. Perforated cerclage pessaries (Dr. Arabin GmbH & Co. KG) will be placed in specialized
      clinic and will be removed at 37 weeks.

      Size of the sampling and statistical analysis: This multicenter pilot study will be conducted
      in High-Risk Pregnancies Clinics in Quebec and in Ontario.

      Over the 12 months period, the investigators expect to collect data from 26 000 abdominal
      ultrasounds. In accordance with the anticipated recruitment level of 0.9%, the investigators
      planned on enrolling 250 women. Within those women, 125 will be assigned randomly to the
      "progesterone" group and 125 to the "progesterone and pessary" group (1:1 ratio).

      Perspective: This pilot study is designed to identify the challenges and provide strategies
      to deal with them in a larger study. Providing its feasibility, this study will lead to a
      definitive randomized controlled trial (including over 70 centers) to test the effectiveness
      of pessary and progesterone in preventing preterm birth.
    

Intervention name(s): Prometrium; Dr. Arabin, cerclage pessary perforated
Intervention type(s): Drug; Device
Intervention description(s): Intravaginal use, off label, of Prometrium; A Dr. Arabin, cerclage pessary perforated will be inserted participants diagnosed with a short cervix
Other intervention name(s): Progesterone; Pessary
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled clinical trial.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Preterm birth; Short cervix; Pessary; Progesterone