Ongoing or recently completed (since 01/2023) interventional postpartum pilot RCTs addressing (principally) primary VTE prevention in people with combinations of VTE risk factors in the postpartum period
| Trial . | Pilot PARTUM (NCT04153760) . | PP-HEP (NCT05878899) . | LEAP (NCT05058924) . |
|---|---|---|---|
| Status | Ongoing, recruiting | Closed (March 2023) | Ongoing, recruiting |
| Sponsor | University of Calgary | University Hospital Geneva | Mount Sinai Hospital, Canada |
| Study design | Multicenter, multinational, placebo-controlled, double-blind pilot RCT | Single-center pilot open-label RCT | Single-center pilot open-label RCT |
| Intervention | ASA (81 mg once daily) vs placebo once daily for 6 weeks | Enoxaparin 20-60 mg once daily (according to body weight) for 10 days vs no treatment | 3 weeks of prophylactic LMWHa followed by 3 weeks of ASA (81 mg once daily) vs prophylactic LMWHa for 6 weeks |
| Inclusion criteria (summarized)a | ONE (or more) First Order Criterion: 1. Known inherited thrombophilia prior to enrollment 2. Antepartum immobilization (strict bedrest) for ≥7 days. OR TWO (or more) Second Order Criteria: 1. Prepregnancy BMI ≥30 kg/m2 2. Smoking ≥5 cigarettes/day prepregnancy 3. Previous clinical history of superficial vein thrombosis 4. Pre-eclampsia 5. Current pregnancy ending in stillbirth (>20/40) 6. Emergency cesarean birth 7. Small-for-gestational-age infant at time of delivery 8. Postpartum infection 9. Postpartum hemorrhage (>1000 mL) | Postpartum women within 48 h of delivery, with at least ONE of: 1. Emergency cesarean section 2. Prepregnancy BMI ≥35 kg/m2 3. Known low-risk thrombophilia 4. Preeclampsia 5. Preterm delivery 6. Peripartum systemic infection 7. Intrauterine growth restriction AND/OR at least 2 of: 1. Age ≥35 years 2. Pre-pregnancy BMI 30.0-34.9 kg/m2 3. Current smoking 4. Elective cesarean section 5. Postpartum hemorrhage 6. Antenatal immobility | >18 years of age AND: 1. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation. OR 2. Family history (first-degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency OR 3. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (first-degree relative) |
| Exclusion criteria (summarized)a | 1. >48 hours since delivery of the placenta at randomization. 2. Received >2 doses of LMWH since delivery of the placenta 3. Need for postpartum LMWH. prophylaxis/systemic anticoagulationb 4. Need for postpartum ASAb 5. Contraindication to ASAa 6. <18 years of age 7. Unable or refused consent | 1. Indication for therapeutic anticoagulation 2. High risk of postpartum VTE 3. Increased bleeding risk 4. Contraindication to heparin 5. Age <18 years | 1. Preexisting indication for therapeutic LMWH 2. Contraindication to ASAa 3. Contraindication to LMWHa 4. Active bleeding, excluding physiologic vaginal bleeding 5. Bleeding disorders 6. Known severe hypertension |
| Pilot trial primary objective | Mean recruitment rate per center per month, calculated over 6 months | Recruitment rate (number of study inclusions per month over 6 months) and proportion of participationa | Enrollment rate, consent rate, adherence to prescription, withdrawal of consent rate, rates of contaminationa |
| Target sample size | 384 | 100-200 | 50 |
| Trial . | Pilot PARTUM (NCT04153760) . | PP-HEP (NCT05878899) . | LEAP (NCT05058924) . |
|---|---|---|---|
| Status | Ongoing, recruiting | Closed (March 2023) | Ongoing, recruiting |
| Sponsor | University of Calgary | University Hospital Geneva | Mount Sinai Hospital, Canada |
| Study design | Multicenter, multinational, placebo-controlled, double-blind pilot RCT | Single-center pilot open-label RCT | Single-center pilot open-label RCT |
| Intervention | ASA (81 mg once daily) vs placebo once daily for 6 weeks | Enoxaparin 20-60 mg once daily (according to body weight) for 10 days vs no treatment | 3 weeks of prophylactic LMWHa followed by 3 weeks of ASA (81 mg once daily) vs prophylactic LMWHa for 6 weeks |
| Inclusion criteria (summarized)a | ONE (or more) First Order Criterion: 1. Known inherited thrombophilia prior to enrollment 2. Antepartum immobilization (strict bedrest) for ≥7 days. OR TWO (or more) Second Order Criteria: 1. Prepregnancy BMI ≥30 kg/m2 2. Smoking ≥5 cigarettes/day prepregnancy 3. Previous clinical history of superficial vein thrombosis 4. Pre-eclampsia 5. Current pregnancy ending in stillbirth (>20/40) 6. Emergency cesarean birth 7. Small-for-gestational-age infant at time of delivery 8. Postpartum infection 9. Postpartum hemorrhage (>1000 mL) | Postpartum women within 48 h of delivery, with at least ONE of: 1. Emergency cesarean section 2. Prepregnancy BMI ≥35 kg/m2 3. Known low-risk thrombophilia 4. Preeclampsia 5. Preterm delivery 6. Peripartum systemic infection 7. Intrauterine growth restriction AND/OR at least 2 of: 1. Age ≥35 years 2. Pre-pregnancy BMI 30.0-34.9 kg/m2 3. Current smoking 4. Elective cesarean section 5. Postpartum hemorrhage 6. Antenatal immobility | >18 years of age AND: 1. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation. OR 2. Family history (first-degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency OR 3. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (first-degree relative) |
| Exclusion criteria (summarized)a | 1. >48 hours since delivery of the placenta at randomization. 2. Received >2 doses of LMWH since delivery of the placenta 3. Need for postpartum LMWH. prophylaxis/systemic anticoagulationb 4. Need for postpartum ASAb 5. Contraindication to ASAa 6. <18 years of age 7. Unable or refused consent | 1. Indication for therapeutic anticoagulation 2. High risk of postpartum VTE 3. Increased bleeding risk 4. Contraindication to heparin 5. Age <18 years | 1. Preexisting indication for therapeutic LMWH 2. Contraindication to ASAa 3. Contraindication to LMWHa 4. Active bleeding, excluding physiologic vaginal bleeding 5. Bleeding disorders 6. Known severe hypertension |
| Pilot trial primary objective | Mean recruitment rate per center per month, calculated over 6 months | Recruitment rate (number of study inclusions per month over 6 months) and proportion of participationa | Enrollment rate, consent rate, adherence to prescription, withdrawal of consent rate, rates of contaminationa |
| Target sample size | 384 | 100-200 | 50 |
Full criteria are available for the relevant trials on clinicaltrials.gov.
As judged by physician and/or local investigator.
ASA, aspirin; × /40, × weeks' gestational age.