A pilot study assessing the feasibility of a randomized controlled trial evaluatingaspirin in postpartum women at risk of developing venous thromboembolism - the PARTUM pilot trial
- Conditions
- Aspirin in postpartum women at risk of developing venous thromboembolismMedDRA version: 21.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2020-000619-58-NL
- Lead Sponsor
- The University of Calgary
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 336
ONE (or more) First Order Criterion:
1. Known inherited thrombophilia diagnosed prior to enrolment. The necessary
laboratory results must be available to confirm the diagnosis. Women with one of the
following thrombophilias will be eligible for the trial, regardless of family history of
VTE:
i) Heterozygous factor V Leiden (genotyping result required), or
ii) Heterozygous prothrombin gene variant (genotyping result required), or
iii) Protein C deficiency (two abnormal and no normal tests based on local laboratory
cutoffs), or
iv) Protein S deficiency (two abnormal and no normal tests, one of which is done
outside of pregnancy/postpartum OR two abnormal tests in
pregnancy/postpartum and one abnormal test and no normal tests in a first
degree relative, based on local laboratory cutoffs), or
2. Antepartum immobilization (strict bedrest) for =7 days. Immobilization is defined as
bed rest with 90% of waking hours spent in bed at any time during the antepartum
period
TWO (or more) Second Order Criteria:
1. Pre-pregnancy BMI =30 kg/m2 (when possible, a documented pre-pregnancy height
and weight will be used when available)
2. Smoking =5 cigarettes/day pre-pregnancy (smoking history is based on prepregnancy
history, irrespective of whether they continue or stop smoking during their
pregnancy)
3. Previous clinical history of superficial vein thrombosis
4. Pre-eclampsia (SBP =140 and/or DBP =90 mmHg on at least one occasion and
proteinuria of =0.3 grams/24 hours or =30 mg/mmol on a random urine sample
diagnosed during pregnancy)
5. Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)
6. Emergency cesarean birth (emergency = not previously planned)
7. Small-for-gestational-age infant at time of delivery (<3rd percentile adjusted for
gestational age and sex using the standardized international INTERGROWTH
chart)
8. Postpartum infection (symptoms/signs of infection and documented fever and
laboratory evidence of infection with positive blood cultures or an elevated white
blood cell count based on local laboratory cutoffs)
9. Postpartum hemorrhage (>1000 mL of blood loss, regardless of delivery mode)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Women will be excluded from the trial if they have a known increased risk of VTE where
there is sufficiently high risk and/or adequate evidence to determine that LMWH or ASA
is indicated, based on their physician and/or local investigator, with examples listed
below.
The trial exclusion criteria are as listed:
1. More than 48 hours since delivery of the placenta at the time of randomization
2. Received more than 2 doses of LMWH since delivery of the placenta*
3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by
their physician and/or local investigator. May include but is not limited to:
a. Documented history of provoked or unprovoked VTE
b. Mechanical heart valve(s)
c. Known antiphospholipid syndrome (APS) (according to the revised
Sapporo/Sydney criteria)
d. Known high-risk inherited thrombophilia
i) Antithrombin deficiency (two abnormal and no normal tests based on local
laboratory cutoffs)
ii) Homozygous factor V Leiden (genotyping result required)
iii) Homozygous prothrombin gene mutation (genotyping result required)
iv) Compound heterozygosity factor V Leiden and prothrombin gene mutation
(genotyping result required)
v) More than 1 thrombophilia: any combination of 2 or more: factor V Leiden,
prothrombin gene mutation, protein C deficiency, protein S deficiency, as
previously defined.
4. Need for postpartum ASA as judged by their physician and/or local investigator. May
include but is not limited to:
a. Documented history of myocardial infarction
b. Documented history of ischemic stroke or transient ischemic attack (TIA)
5. Contraindication to ASA including**:
a. History of known ASA allergy
b. Documented history of a gastrointestinal ulcer
c. Known platelet count <50 x 109/L at any time during the current pregnancy or
postpartum
d. Active bleeding at any site, excluding normal vaginal bleeding, at the time of
randomization
e. Most recent known hemoglobin =70 g/L documented during the current
pregnancy or postpartum
f. Known severe hypertension (SBP >200 mmHg and/or DBP >120 mmHg) during
the current pregnancy or postpartum
6. <18 years of age
7. Unable or refused consent
*Pneumatic compression devices or graduated compression stockings are not a
contraindication to enrolment but will be recorded.
**Postpartum non-steroidal anti-inflammatories (NSAID) use is not a contraindication to
enrolment but will be recorded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method