Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

Phase 1

• Conditions: Post-Partum Venous thromboembolism prophylaxis; MedDRA version: 21.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-000619-58-FR
• Lead Sponsor: CHU SAINT-ETIENNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-26
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Trial inclusion criteria includes one (or more) first order criterion or two (or more) second order criterion. A patient is still eligible if they have multiple criteria met, at the discretion of their physician and/or local investigator.
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 andlaboratory 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 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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)55
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