MiscarriagePhase 2NCT02145767
Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
A Phase 2 study testing Progesterone in people with Miscarriage and Preterm Birth, run by Sir Mortimer B. Davis - Jewish General Hospital at 7 sites in Canada.
Trial summary
Miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. 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
- Miscarriage, Preterm Birth
- What is being tested?
- Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 7 sitesCanada
- Study dates
- Dec 2014to Feb 2021
- Phase
- Phase 2
- 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
- Live intrauterine singleton pregnancy of <14 weeks by crown-rump length on ultrasound with documented fetal cardiac activity
- Presence of a perigestational (subchorionic) hemorrhage on ultrasound
Who cannot join
- Contraindication to Progesterone
- Any indication for progesterone
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Karma Medical Clinic
Kitchener, Ontario, N2H 5Z8
Jewish General Hospital
Montreal, Quebec, H3T 1E2
CHU Sainte-Justine
Montreal, Quebec
MUHC Royal Victoria Hospital
Montreal, Quebec
St. Mary's Hospital
Montreal, Quebec
North York General Hospital
North York, Ontario
Hôpital Fleurimont
Sherbrooke, Quebec, J1H 5N4
About this study
Miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key role during pregnancy, has been proposed as a possible medication to be used in pregnancy to prevent miscarriage and preterm birth among women who have bleeding in their first trimester of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The purpose of our study is to evaluate the effect of progesterone for the prevention of miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a clinical trial in which 850 women will be randomized to receive either progesterone supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of their pregnancy will be compared.
- Conditions
- Miscarriage, Preterm Birth
- Being tested
- Progesterone, Placebo
- Medical subject headings
- Abortion, Spontaneous, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy. Receives: Drug: Progesterone |
| Placebo | Placebo comparator | Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage
Occurrence of a miscarriage (<20 weeks)
Measured: From 6-8 weeks of pregnancy until miscarriage
Preterm birth
Occurrence of preterm birth (<37 weeks)
Measured: From 6-8 weeks of pregnancy until delivery
Secondary outcomes (3)
Maternal outcomes
Antenatal admissions, treatment of preterm labor etc.
Measured: From 6-8 weeks of pregnancy until 6 weeks post delivery
Neonatal outcomes
Malformations, growth restriction, prematurity associated morbidity, etc.
Measured: 2 days to 6 weeks post delivery
Healthcare outcomes
Hospital costs, etc
Measured: From 6-8 weeks of pregnancy until 6 weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Haim Abenhaim, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Haim Abenhaim, MD, MPH, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145767
- Sponsor's protocol ID
- PRMT15
- Status last verified
- Aug 2021
- First submitted
- 14 May 2014
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
- ClinicalTrials.gov ID
- NCT02145767
- Acronym / sponsor ID
- PRMT15
- Conditions
- Miscarriage, Preterm Birth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 23 May 2014 (estimated)
- 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.
Miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key role during pregnancy, has been proposed as a possible medication to be used in pregnancy to prevent miscarriage and preterm birth among women who have bleeding in their first trimester of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The purpose of our study is to evaluate the effect of progesterone for the prevention of miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a clinical trial in which 850 women will be randomized to receive either progesterone supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of their pregnancy will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: ProgesteroneProgesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy. |
| Placebo | Placebo comparator | Drug: PlaceboSimilar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Live intrauterine singleton pregnancy of <14 weeks by crown-rump length on ultrasound with documented fetal cardiac activity
- Presence of a perigestational (subchorionic) hemorrhage on ultrasound
Key exclusion criteria (2 listed)
- Contraindication to Progesterone
- Any indication for progesterone
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 |
|---|---|---|
| Progesterone | Drug | Progesterone |
| Placebo | Drug | Placebo |
Primary outcome
Miscarriage
Time frame: From 6-8 weeks of pregnancy until miscarriage
Occurrence of a miscarriage (<20 weeks)
Preterm birth
Time frame: From 6-8 weeks of pregnancy until delivery
Occurrence of preterm birth (<37 weeks)
3 secondary outcomes
Maternal outcomes
Time frame: From 6-8 weeks of pregnancy until 6 weeks post delivery
Neonatal outcomes
Time frame: 2 days to 6 weeks post delivery
Healthcare outcomes
Time frame: From 6-8 weeks of pregnancy until 6 weeks post delivery
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 23 Aug 2021.
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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.
Haim Abenhaim, MD, MPH principal investigator
Jewish General Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progesterone in people with Miscarriage and Preterm Birth, run by Sir Mortimer B. Davis - Jewish General Hospital at 7 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 2 inclusion and 2 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Miscarriage (time frame: From 6-8 weeks of pregnancy until miscarriage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2021.