Preterm LaborPhase 2EAU2-MtlkNCT02108886
Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth
A Phase 2 study testing Montelukast and urine and vaginal secretions sampling in people with Preterm Labor, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Preterm birth is a major public health problem, and actual treatments are not very efficient. The purpose of this study is to test the efficiency of a combined use of Montelukast and Nifedipine to treat preterm labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Montelukast and urine and vaginal secretions sampling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Dec 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with 24-34 weeks of pregnancy
- indication for tocolysis
Who cannot join
- preterm labor before 26 or after 34 weeks of pregnancy
- minor patients
- patients with other obstetrical pathology
- twin pregnancies
- fetal distress
- severe congenital fetal malformation
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- anti-phospholipid syndrome
- lupus
- gestational diabetes
- nephropathy
- congenital heart disease
- obvious causes of infection associated with prematurity
- patients with viral infections (HIV, hepatitis)
- patients already treated with Montelukast
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.
Preterm birth is a major public health problem, and actual treatments are not very efficient. The purpose of this study is to test the efficiency of a combined use of Montelukast and Nifedipine to treat preterm labor. Investigators aim to reduce uterine contractions more efficiently than with the use of Nifedipine only.
Read the detailed description
An inflammatory process is involved in 60% of preterm births. Moreover, investigators previously demonstrated that enzymes of lipoxygenase pathway are present in uterine smooth muscle, and that an additive tocolytic effect can be obtained from the combined use of Montelukast and Nifedipine.
Methods:
This is a double-blinded randomized controlled assay performed at the CHUS on two groups of 50 women. Women will be selected when admitted for preterm labor with a gestational age between 26 and 34 weeks.
The first group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to 10 mg of Montelukast per day, until delivery or 35 weeks of pregnancy.
The second group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to a placebo per day, until delivery or 35 weeks of pregnancy.
Cervical secretions and urine will be sample at the admission, after one week and every two weeks during treatment.
- Conditions
- Preterm Labor
- Being tested
- Montelukast, Placebo, urine and vaginal secretions sampling
- Keywords
- preterm labor, montelukast, uterine contractions
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.
PlaceboDrug
empty capsule filled with sugar
urine and vaginal secretions samplingOther
Urine and vaginal secretions sampling, once a week in both groups
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | Intervention group Receives: Drug: Montelukast; Other: urine and vaginal secretions sampling |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo; Other: urine and vaginal secretions sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between beginning of treatment and delivery
Measured: until delivery (max 17 weeks)
Secondary outcomes (2)
preterm birth
birth before 37 weeks of gestation
Measured: until delivery (max 13 weeks)
chorio decidual infection
Measured: between inclusion and delivery (max 17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionJul 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- 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
- NCT02108886
- Sponsor's protocol ID
- 11-143
- Acronym
- EAU2-Mtlk
- Status last verified
- Mar 2015
- First submitted
- 15 Jan 2013
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.
- ClinicalTrials.gov ID
- NCT02108886
- Acronym / sponsor ID
- EAU2-Mtlk / 11-143
- Conditions
- Preterm Labor
- Keywords
- preterm labor, montelukast, uterine contractions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Apr 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.
Preterm birth is a major public health problem, and actual treatments are not very efficient. The purpose of this study is to test the efficiency of a combined use of Montelukast and Nifedipine to treat preterm labor. Investigators aim to reduce uterine contractions more efficiently than with the use of Nifedipine only.
Detailed description
An inflammatory process is involved in 60% of preterm births. Moreover, investigators previously demonstrated that enzymes of lipoxygenase pathway are present in uterine smooth muscle, and that an additive tocolytic effect can be obtained from the combined use of Montelukast and Nifedipine.
Methods:
This is a double-blinded randomized controlled assay performed at the CHUS on two groups of 50 women. Women will be selected when admitted for preterm labor with a gestational age between 26 and 34 weeks.
The first group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to 10 mg of Montelukast per day, until delivery or 35 weeks of pregnancy.
The second group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to a placebo per day, until delivery or 35 weeks of pregnancy.
Cervical secretions and urine will be sample at the admission, after one week and every two weeks during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Montelukast, Other: urine and vaginal secretions samplingIntervention group |
| Placebo | Placebo comparator | Drug: Placebo, Other: urine and vaginal secretions samplingPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women with 24-34 weeks of pregnancy
- indication for tocolysis
Key exclusion criteria (14 listed)
- preterm labor before 26 or after 34 weeks of pregnancy
- minor patients
- patients with other obstetrical pathology
- twin pregnancies
- fetal distress
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 |
|---|---|---|
| MontelukastAlso: Singulair10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy. | Drug | Montelukast |
| Placeboempty capsule filled with sugar | Drug | Placebo |
| urine and vaginal secretions samplingUrine and vaginal secretions sampling, once a week in both groups | Other | Montelukast, Placebo |
Primary outcome
Time between beginning of treatment and delivery
Time frame: until delivery (max 17 weeks)
2 secondary outcomes
preterm birth
Time frame: until delivery (max 13 weeks)
chorio decidual infection
Time frame: between inclusion and delivery (max 17 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Montelukast and urine and vaginal secretions sampling in people with Preterm Labor, run by Université de Sherbrooke at 1 site 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 14 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: status not confirmed, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Time between beginning of treatment and delivery (time frame: until delivery (max 17 weeks)). 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 4 Mar 2015.