Preterm BirthCAPPNCT03227705
Canadian Study on the Association of Pessary With Progesterone
A study testing Prometrium and Dr. Arabin, cerclage pessary perforated in people with Preterm Birth and Short Cervix, run by Université de Sherbrooke at 8 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Short Cervix
- What is being tested?
- Prometrium and Dr. Arabin, cerclage pessary perforated
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 8 sitesCanada
- Study dates
- 4 Jun 2018to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Kingston General Hospital
Kingston, Ontario
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
CIUSSS du Centre Ouest-de-l'Île-de Montréal
Montreal, Quebec, H3T 1E2
St.Mary's Hospital Center
Montreal, Quebec
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
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.
Read the 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.
- Conditions
- Preterm Birth, Short Cervix
- Being tested
- Prometrium, Dr. Arabin, cerclage pessary perforated
- Keywords
- Preterm birth, Short cervix, Pessary, Progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrometriumDrug
Also called Progesterone
Intravaginal use, off label, of Prometrium
Dr. Arabin, cerclage pessary perforatedDevice
Also called Pessary
A Dr. Arabin, cerclage pessary perforated will be inserted participants diagnosed with a short cervix
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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. Receives: Drug: Prometrium; Device: Dr. Arabin, cerclage pessary perforated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks (18 to 42 weeks of gestation)
Secondary outcomes (1)
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 ".
Measured: Before 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start4 Jun 2018
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), CHU de Quebec-Universite Laval, St. Justine's Hospital, Jewish General Hospital, The Ottawa Hospital, Queen's University
- Responsible party
- Principal investigator, Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke
- Investigators
- Jean-Charles Pasquier, MD, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227705
- Sponsor's protocol ID
- 13-159
- Acronym
- CAPP
- Status last verified
- Apr 2023
- First submitted
- 12 Jul 2017
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36453699
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Study on the Association of Pessary With Progesterone
- ClinicalTrials.gov ID
- NCT03227705
- Acronym / sponsor ID
- CAPP / 13-159
- Conditions
- Preterm Birth, Short Cervix
- Keywords
- Preterm birth, Short cervix, Pessary, Progesterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), CHU de Quebec-Universite Laval, St. Justine's Hospital, Jewish General Hospital, The Ottawa Hospital, Queen's University
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intravaginal progesterone | Active comparator | Drug: PrometriumOnce 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 progesterone and pessary | Experimental | Drug: Prometrium, Device: Dr. Arabin, cerclage pessary perforatedOnce 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrometriumAlso: ProgesteroneIntravaginal use, off label, of Prometrium | Drug | Intravaginal progesterone, Intravaginal progesterone and pessary |
| Dr. Arabin, cerclage pessary perforatedAlso: PessaryA Dr. Arabin, cerclage pessary perforated will be inserted participants diagnosed with a short cervix | Device | Intravaginal progesterone and pessary |
Primary outcome
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.
1 secondary outcome
Preterm delivery
Time frame: Before 34 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 36453699Abdel-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Pasquier, MD, PhD principal investigator
Université de Sherbrooke
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prometrium and Dr. Arabin, cerclage pessary perforated in people with Preterm Birth and Short Cervix, run by Université de Sherbrooke at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: Up to 24 weeks (18 to 42 weeks of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03227705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.