Canadian Study on the Association of Pessary With Progesterone

Preterm Birth Clinical Trial

— CAPP  

Official title:

Canadian Study on the Association of Pessary With Progesterone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227705
• Other study ID #: 13-159
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: October 6, 2022

Study information

• Verified date: April 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth
• Short Cervix

Intervention

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

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

Canada, 

Outcome

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

External Links

•   Clinical trial website