Post-Partum Venous thromboembolism prophylaxis MedDRA version: 21.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Acethylsalicylic acid
Product Name: Acethylsalicylic acid
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
CHU SAINT-ETIENNE
Eligibility
Sex/Gender
All
Inclusion criteria
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 (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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the pilot trial is to determine the mean recruitment rate per centre per month, calculated over 6 months.;Secondary Objective: Evaluation of : 1. Consent rates for eligible women who are approached 2. Rate of study withdrawal or loss to follow-up 3. Compliance rate with the study drug 4. Time required to obtain REB/EC approvals and contract agreements at each site 5. A more precise estimate of the VTE event rate 6. More precise estimate of the major and clinically relevant non-major bleeding event rates;Primary end point(s): Subject recruitment rate/centre/month. Target : 4 subjects/centre/month;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of eligible patients who provide consent. Target : More than 30% Withdrawals/loss to follow-up. Target : Less than 15% Proportion of sites with >18 months to REB and contract approval from the time of delivery of all study documents. Target : Less than 25% Level of compliance with study drug >80% taken. taget More than 70%;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
France, Netherlands
Contacts
Public ContactProject Manager
CHU Saint-Etienne
Outcome results
None listed