Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

Venous Thromboembolism Clinical Trial

— PARTUM  

Official title:

A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153760
• Other study ID #: REB19-1237
• Status: Completed
• Phase: Early Phase 1
• Start date: October 7, 2020
• Est. completion date: September 5, 2023

Study information

• Verified date: September 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.

Description:

The purpose of the pilot PARTUM trial is to determine whether it is feasible to conduct a larger randomized controlled trial to determine whether low-dose aspirin is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo. Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of aspirin 81 mg versus placebo, the investigators first need to determine if it is possible to recruit enough women. If the pilot trial is successful and there are no major changes to the study design, then the secondary clinical outcomes collected in the pilot trial will be used in the analysis of the full multicenter trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Study inclusion criteria includes one (or more) first order criterion or two (or more) second order criteria. A patient is still eligible if they have multiple criteria met, at the discretion of the local investigator.

ONE (or more) First Order Criteria:

1. Known inherited thrombophilia diagnosed prior to enrolment:

i) Heterozygous factor V Leiden, OR ii) Heterozygous prothrombin gene variant, OR iii) Protein C deficiency, OR iv) Protein S deficiency

2. Immobilization (90% of waking hours spent in bed) for =7 days anytime during the antepartum period

TWO (or more) Second Order Criteria:

1. Postpartum infection

2. Postpartum hemorrhage (>1000 mL of blood loss, regardless of delivery mode)

3. Pre-pregnancy BMI =30 kg/m2

4. Emergency or unplanned cesarean delivery

5. Smoking =5 cigarettes/day before pregnancy

6. Pre-eclampsia

7. Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)

8. Small-for-gestational-age infant (<3rd percentile adjusted for gestational age and sex).

9. Previous history of superficial vein thrombosis

Exclusion Criteria:

1. More than 48 hours since delivery

2. Received more than 2 doses of low-molecular-weight heparin (LMWH) since delivery

3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by the

local investigator. May include but is not limited to:

1. Documented history of provoked or unprovoked VTE

2. Mechanical heart valve(s)

3. Known antiphospholipid syndrome

4. Known high-risk inherited thrombophilia i) Antithrombin deficiency; ii) Homozygous factor V Leiden; iii) Homozygous prothrombin gene mutation; iv) Compound heterozygosity factor V Leiden and prothrombin gene mutation; v) More than one inherited thrombophilia

4. Need for postpartum aspirin as judged by the local investigator. May include but is

not limited to:

1. Documented history of myocardial infarction

2. Documented history of ischemic stroke or transient ischemic attack (TIA)

5. Contraindication to aspirin including:

1. History of known aspirin allergy

2. Documented history of a gastrointestinal ulcer

3. Known platelet count <50 x 109/L at any time during the current pregnancy or postpartum

4. Active bleeding at any site, excluding normal vaginal bleeding, at the time of randomization

5. Most recent known hemoglobin =70 g/L documented during the current pregnancy or postpartum

6. Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum

6. <18 years of age

7. Unable or refused consent

Related Conditions & MeSH terms

• Aspirin
• Postpartum Period
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Aspirin 81 mg
Aspirin 81 mg p.o. daily
• Placebo
Placebo p.o. daily

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	British Columbia Women's Hospital & Health Centre	Vancouver	British Columbia
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Étienne	Loire
Ireland	Rotunda Hospital	Dublin
Netherlands	The Amsterdam Medical Centre	Amsterdam	North Holland

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Countries where clinical trial is conducted

Canada,  France,  Ireland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Mean recruitment rate per center per month	6 months
Secondary	Consent Rate	Proportion of eligible subjects who provide consent	6 months
Secondary	Withdrawals/Loss to Follow-up	Proportion of withdrawals/loss to follow-up among participants	9 months
Secondary	Study Drug Compliance	Level of compliance with study drug through participant recall and medication diary	6 months
Secondary	Time Required to Obtain Site Institutional Approvals	Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.	24 months
Secondary	VTE Event Rate	A more precise estimate of the VTE event rate	6 months
Secondary	Bleeding Event Rate	A more precise estimate of the major and clinically relevant non-major bleeding event rate	6 months