- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03227705
Canadian Study on the Association of Pessary With Progesterone (CAPP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie-Belle Poirier, PhD
- Phone Number: 12865 8193461110
- Email: Marie-Belle.Poirier@USherbrooke.ca
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada
- Kingston General Hospital
-
Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital
-
-
Quebec
-
Montréal, Quebec, Canada, H2X 0C1
- Centre Hospitalier de l'Universite de Montreal
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Montréal, Quebec, Canada, H3T 1C5
- CHU Sainte-Justine
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Montréal, Quebec, Canada, H3T 1E2
- CIUSSS du Centre Ouest-de-l'Île-de Montréal
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Montréal, Quebec, Canada
- St.Mary's Hospital Center
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Quebec city, Quebec, Canada, G1V 4G2
- CHU de Quebec-Universite Laval
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Universite de Sherbrooke
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 previa - cerclage of the cervix in place - antecedent of conisation - multiple gestation - ballooning of membranes outside the cervix into the vagina - allergy/intolerance or hypersensitivity to progesterone or any of its ingredients - chronic medical conditions that would interfere with study participation or evaluation of treatment - vaginal administration of another drug.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intravaginal progesterone
Once the participant agrees and signs the consent form, the use of prophylactic progesterone will begin (PROMETRIUM, 200 mg in total of progesterone, 2 vaginal capsules per day at bedtime up to 36 6/7 weeks of gestation, Merck Canada Inc.)
|
Intravaginal use, off label, of Prometrium
Other Names:
|
Experimental: Intravaginal progesterone and pessary
Once the participant agrees and signs the consent form, the use of prophylactic progesterone will begin (PROMETRIUM, 200 mg in total of progesterone, 2 vaginal capsules per day at bedtime, Merck Canada Inc.).
Also, a perforated pessary (Dr.
Arabin, cerclage pessary perforated) will be inserted.
The pessary will be removed and the progesterone treatment will be stopped at 36 6/7 weeks of gestation.
|
Intravaginal use, off label, of Prometrium
Other Names:
A Dr. Arabin, cerclage pessary perforated will be inserted participants diagnosed with a short cervix
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment feasibility
Time Frame: Up to 24 weeks (18 to 42 weeks of gestation)
|
According to the anticipated recruitment rate, 0.9% of women having an anatomy scan could be included (95% CI, 0.78- 1.04).
We will determine the % of women included in the study (until the 42 week of gestation) over women that received a anatomy scan.
|
Up to 24 weeks (18 to 42 weeks of gestation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preterm delivery
Time Frame: Before 34 weeks
|
The secondary outcome is to determine the occurrence of spontaneous preterm births before 34 weeks in the progesterone alone group " without pessary harm ".
|
Before 34 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-Charles Pasquier, MD, PhD, Universite de Sherbrooke
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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