Comparing 3 approaches for pregnancy
Official title: Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves
A Prospective Multicenter Cohort Pilot Study Comparing Antithrombotic Regimens in Pregnancies With Mechanical Heart Valves
- 3 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
LMWH and LDA
1\) Therapeutic LMWH throughout pregnancy either using weight-based dosing or dosing according to anti-Xa levels. The initial dose will be a twice daily therapeutic dose of 1.35U/kg (pregnancy weight) of enoxaparin or 135 U/kg (pregnancy weight) of dalteparin using prefilled syringes titrated to the higher dose prefilled syringe (i.e., not below the pregnancy weight-based dosing). 1. The dose of therapeutic LMWH can be adjusted by anti-Xa (done at least after four days of the start of LMWH or change in LMWH dose) levels or by pregnancy weight however, weight and anti-Xa levels will be determined for all participants using LMWH. Pregnancy weight in kilograms is to be determined every month. 2. If therapeutic LMWH is adjusted according to anti-Xa levels, peak and trough anti-Xa levels (done at least after four days of the start of LMWH or change in LMWH dose) are to be sent every four weeks or weekly if there is a change in dose.
- Other intervention
Vitamin K antagonists (e.g warfarin)+/- LDA
VKAs during pregnancy: VKA use will require INRs every two weeks or weekly (done at least 5 days after starting or changing the dose) if there is a change in doses to ensure an INR of 2.5 for a patient with an aortic MVR (INR of 2 for the On-X AVR) and 3 for mitral MVR or two MHVs is met. LDA 81 mg to be added once pregnancy is confirmed.
- Other intervention
Sequential therapy +/- LDA
LMWH at 6 weeks gestation until 12 weeks gestation prescribed according to the regimens above then VKAs from 12 weeks gestation until 34-36 weeks gestation followed by twice daily LMWH according to doses above until delivery. LDA to be added when pregnancy is confirmed
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Who consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate
- +Are 18 years or older and
- +Less than 12 weeks gestation
- +Pregnant individuals with one or more MHVs
Exclusion
- −Have a platelet count less than 50 x 10(9)/L as there is an increased risk of bleeding with thrombocytopenia, and/or
- −Have active bleeding defined as bleeding resulting in a hemoglobin reduction ≥10 g/L or in hemodynamic instability.
- −Have new valve thrombosis identified immediately prior to pregnancy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives LMWH and LDA.
Registry label: A: LMWH and LDA
Group B receives Vitamin K antagonists (e.g warfarin)+/- LDA.
Registry label: B: Vitamin K antagonists (e.g warfarin)+/- LDA
Group C receives Sequential therapy +/- LDA.
Registry label: C: Sequential therapy +/-LDA
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 45 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Primary outcomePrimary endpointThe single main question the study is designed to answer.Read more → Measures — measured over At baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
Adherence rate — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → until birth.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07658989 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LMWH and LDADrug
1\) Therapeutic LMWH throughout pregnancy either using weight-based dosing or dosing according to anti-Xa levels. The initial dose will be a twice daily therapeutic dose of 1.35U/kg (pregnancy weight) of enoxaparin or 135 U/kg (pregnancy weight) of dalteparin using prefilled syringes titrated to the higher dose prefilled syringe (i.e., not below the pregnancy weight-based dosing). 1. The dose of therapeutic LMWH can be adjusted by anti-Xa (done at least after four days of the start of LMWH or change in LMWH dose) levels or by pregnancy weight however, weight and anti-Xa levels will be determined for all participants using LMWH. Pregnancy weight in kilograms is to be determined every month. 2. If therapeutic LMWH is adjusted according to anti-Xa levels, peak and trough anti-Xa levels (done at least after four days of the start of LMWH or change in LMWH dose) are to be sent every four weeks or weekly if there is a change in dose.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Vitamin K antagonists (e.g warfarin)+/- LDAOther
VKAs during pregnancy: VKA use will require INRs every two weeks or weekly (done at least 5 days after starting or changing the dose) if there is a change in doses to ensure an INR of 2.5 for a patient with an aortic MVR (INR of 2 for the On-X AVR) and 3 for mitral MVR or two MHVs is met. LDA 81 mg to be added once pregnancy is confirmed.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Sequential therapy +/- LDAOther
LMWH at 6 weeks gestation until 12 weeks gestation prescribed according to the regimens above then VKAs from 12 weeks gestation until 34-36 weeks gestation followed by twice daily LMWH according to doses above until delivery. LDA to be added when pregnancy is confirmed
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 45 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
The study as a whole is currently expected to finish around 2030-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this pilot study is to collect data on pregnancies with mechanical heart valves to see if using a blood thinner called low molecular weight heparin (LMWH) and low dose aspirin (LDA) is comparable to warfarin/vitamin K antagonist (VKA) to reduce the chance of clotting around the mechanical valve and improve survival. The study is a pilot study as the study investigators need to ensure that the blood levels needed for adequate amounts of LMWH and warfarin can be maintained during pregnancy to be able to compare LMWH and aspirin to warfarin. If this study shows that we can collect the tests that are needed for a larger study, the individuals' information who participated in this pilot study will be moved to the larger study. The larger study will compare survival, clot development and cardiac function as well as safety of these two common blood thinners.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.