Preterm Birth Clinical Trial
— CAPPOfficial title:
Canadian Study on the Association of Pessary With Progesterone
NCT number | NCT03227705 |
Other study ID # | 13-159 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2018 |
Est. completion date | October 6, 2022 |
Verified date | April 2023 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | October 6, 2022 |
Est. primary completion date | October 6, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | Centre hospitalier de l'Université de Montréal | Montréal | Quebec |
Canada | CHU Sainte-Justine | Montréal | Quebec |
Canada | CIUSSS du Centre Ouest-de-l'Île-de Montréal | Montréal | Quebec |
Canada | St.Mary's Hospital Center | Montréal | Quebec |
Canada | Ottawa Hospital | Ottawa | Ontario |
Canada | CHU de Québec-Université Laval | Quebec city | Quebec |
Canada | Université de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Centre hospitalier de l'Université de Montréal (CHUM), CHU de Quebec-Universite Laval, Jewish General Hospital, Queen's University, St. Justine's Hospital, The Ottawa Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment feasibility | 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 | Preterm delivery | 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 |
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