Canadian Study on the Association of Pessary With Progesterone

NCT03227705 | Completed DMC

• 1 other identifier: 13-159
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Preterm birth; Short cervix; Pessary; Progesterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Preterm delivery

  Before 34 weeks

Study Arms (2)

Intravaginal progesterone

ACTIVE COMPARATOR

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.)

Drug: Prometrium

Intravaginal progesterone and pessary

EXPERIMENTAL

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.

Drug: Prometrium; Device: Dr. Arabin, cerclage pessary perforated

Interventions

Prometrium DRUG

Intravaginal use, off label, of Prometrium

Also known as: Progesterone

Intravaginal progesterone; Intravaginal progesterone and pessary

Dr. Arabin, cerclage pessary perforated DEVICE

A Dr. Arabin, cerclage pessary perforated will be inserted participants diagnosed with a short cervix

Also known as: Pessary

Intravaginal progesterone and pessary

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• CHU de Quebec-Universite Laval: collaborator
• St. Justine's Hospital: collaborator
• Jewish General Hospital: collaborator
• The Ottawa Hospital: collaborator
• Queen's University: collaborator

Study Sites (8)

Kingston General Hospital

Kingston, Ontario, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

CIUSSS du Centre Ouest-de-l'Île-de Montréal

Montreal, Quebec, H3T 1E2, Canada

Location

St.Mary's Hospital Center

Montreal, Quebec, Canada

Location

CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.

  PMID: 36453699 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone; Pessaries

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Surgical Equipment; Equipment and Supplies

Study Officials

• Jean-Charles Pasquier, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Randomized, controlled clinical trial.

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 24, 2017
• Study Start: June 4, 2018
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)