A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism

Phase 3

Recruiting

• Conditions: deep vein thrombosis; pulmonary emboslism; 10036411; 10014523

• Registration Number: NL-OMON50986
• Lead Sponsor: The University of Calgary

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

ONE (or more) First Order Criterion:
1. Known inherited thrombophilia prior to enrolment: Heterozygous factor V
Leiden or
heterozygous prothrombin gene variant or protein C deficiency or protein S
deficiency
2. Antepartum immobilization (strict bedrest) for >=7 days at any time during the
pregnancy
OR TWO (or more) Second Order Criteria:
1. Pre-pregnancy BMI >=30 kg/m2
2. Smoking >=5 cigarettes/day pre-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)
5. Current pregnancy ending in stillbirth (fetal loss >20 weeks gestation)
6. Emergency cesarean birth (emergency = not 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 and documented fever and laboratory
evidence of infection)
9. Postpartum hemorrhage (>1000 mL regardless of delivery mode)

Exclusion Criteria

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)
Pilot PARTUM Trial Version 1.5 08Jun2020
10
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 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary full trial objective is to determine the efficacy of low-dose ASA<br /><br>of preventing symptomatic VTE in the first 6 weeks postpartum, compared to<br /><br>placebo.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives include:<br /><br>1. Late symptomatic VTE from 6 weeks to 90 days<br /><br>2. Superficial vein thrombosis<br /><br>3. Distal deep vein thrombosis<br /><br>4. Subsegmental pulmonary embolism<br /><br>5. Unusual site thrombosis<br /><br>6. Major bleeding<br /><br>7. Clinically relevant non-major bleeding<br /><br>8. Symptomatic ATE (ischemic stroke/TIA or myocardial infarction or peripheral<br /><br>arterial embolism)<br /><br>9. Postpartum pre-eclampsia<br /><br>10. All-cause mortality</p><br>