PostpartumNCT07716332
Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis
A study testing Apixaban and Enoxaparin in people with Postpartum and DVT Prophylaxis, run by Ron Beloosesky MD.
Trial summary
The purpose of this study is to compare the use of oral apixaban to subcutaneous enoxaparin for venous thromboembolism (VTE) prophylaxis in postpartum women at high risk for VTE. The primary goal is to evaluate medication adherence rates and patient satisfaction with the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum, DVT Prophylaxis
- What is being tested?
- Apixaban and Enoxaparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- After Vaginal or C/S delivery.
- Need prophylactic treatment in a preventive dose.
- Presence of one or more high risk factors: Active infection, IBD, Heart disease, Type 1 diabetes with nephropathy, IV drug user, Surgical operation in Postpartum period, Emergency cesarean section.
- OR presence of 2 low risk factors: Age > 35, post-partum hemorrhage > 1000 ml, Cesarean section, Hysterectomy, BMI > 30, Multiparity- Third birth or more, Active Smoking, Obstetric complications in current pregnancy (including preeclampsia, preterm birth before 37 weeks, active infection including chorioamnionitis, prolonged labor over 24 hours), Twin birth, Immobility, Large varicose veins, Stillbirth
Who cannot join
- Breast feeding.
- Predispose to hypercoagulability
- Familial history of VTE.
- Antiphospholipid syndrome (APS).
- Prior VTE.
- Anticoagulant treatment before or during pregnancy.
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- BMI > 40
- History of severe renal or hepatic disease.
- Use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
- Known diagnosis of bleeding dyscrasia (eg, von Willebrand disease).
- Spinal/epidural hematoma or spinal puncture.
- Active pathological bleeding or high risk of bleeding.
- Hemoglobin > 9 mg/dl before the delivery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Apixaban Versus Enoxaparin for Thromboprophylaxis After Delivery
The purpose of this study is to compare the use of oral apixaban to subcutaneous enoxaparin for venous thromboembolism (VTE) prophylaxis in postpartum women at high risk for VTE. The primary goal is to evaluate medication adherence rates and patient satisfaction with the treatment.
Read the detailed description
Venous thromboembolism (VTE) is a leading cause of pregnancy-related morbidity and mortality. Current guidelines recommend pharmacologic thromboprophylaxis with low-molecular-weight heparin (LMWH), such as enoxaparin, for postpartum women with increased risk factors. However, common patient complaints related to enoxaparin include injection site reaction, pain, bruising, bleeding, nausea, vomiting, and cost. Oral anticoagulation therapy, such as apixaban (an oral factor Xa inhibitor), could obviate many of these negative effects.This single-center, prospective, open-blinded randomized controlled trial aims to investigate the use of apixaban versus enoxaparin for VTE prophylaxis in the postpartum period. Eligible postpartum women (after vaginal or cesarean delivery) with high risk for VTE will be randomized in a 1:1 ratio.
- Conditions
- Postpartum, DVT Prophylaxis
- Being tested
- Apixaban, Enoxaparin
- Keywords
- apixaban, enoxaparin, vte prophylaxis, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called eliquis
Apixaban. 2.5 mg administered orally twice a day
EnoxaparinDrug
Also called clexane
Enoxaparin 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Apixaban. 2.5 mg administered orally twice a day Receives: Drug: Apixaban |
| Enoxaparin | Active comparator | Enoxaparin. 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
Patient-reported treatment convenience assessed using a study-specific questionnaire. The primary measurement is an 11-point general convenience Visual Analog Scale (VAS) where patients rate the overall convenience of their assigned post-partum anticoagulant treatment (oral vs. subcutaneous) from 0 ("Not convenient at all") to 10 ("Very convenient"). Higher scores indicate a higher level of treatment convenience. The outcome also incorporates a categorical question evaluating whether the treatment was easy to take/receive (categorized as: Agree, Neutral, Disagree).
Measured: up to 6 weeks postpartum
Medication Adherence Rate Assessed by Patient Self-Report
Adherence to the prescribed thromboprophylaxis regimen, assessed via patient self-report within the study questionnaire. Adherence is evaluated through targeted categorical questions regarding compliance: (1) whether the patient faced difficulties remembering to take the medication, and (2) whether any dose was missed during the hospitalization period. Responses are categorized as "Agree," "Neutral," or "Disagree." The outcome will be reported as the percentage of patients who demonstrated adherence (i.e., no missed doses and no memory difficulties) versus non-adherent patients
Measured: Up to 6 weeks postpartum
Treatment-Related Pain Intensity Assessed by a Visual Analog Scale (VAS)
Intensity of pain specifically associated with the administration of the assigned anticoagulant therapy. This is evaluated using an 11-point Visual Analog Scale (VAS) embedded in the questionnaire. Patients who report experiencing treatment-related pain rate its intensity on a scale ranging from 0 ("No pain at all") to 10 ("Unbearable pain"). Lower scores indicate lower pain levels and better treatment tolerance.
Measured: Up to 6 weeks postpartum
Patient Treatment Preference and Recommendation Assessed by Self-Report
Patient preference for future short-term preventative treatment options based on their experience during the clinical trial. Patients select their preferred route of administration from three options: Oral tablets, Subcutaneous injections, or No preference. Additionally, the assessment includes a categorical question on whether the patient would recommend their assigned treatment to another person (Categorized as: Agree, Disagree, Do not know). Results will be presented as the proportion (%) of patients in each preference and recommendation category.
Measured: Up to 6 weeks postpartum
Secondary outcomes (7)
Incidence of Venous Thromboembolism (VTE)
Occurrence of VTE event
Measured: up to 6 weeks postpartum
Incidence of major bleeding and bleeding events
Major bleeding and bleeding events defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria.
Measured: up to 6 weeks postpartum
Decrease in hemoglobin values
Comparison of the decrease in hemoglobin levels between the apixaban and enoxaparin study groups. The baseline value is defined as the hemoglobin level measured via complete blood count (CBC) upon the patient's admission to the labor and delivery unit. The final value is the hemoglobin level measured on the day of her clinical discharge from the postpartum ward. The decrease will be calculated for each participant by subtracting the discharge value from the baseline value.
Measured: From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)
Incidence of adverse events
Patient-reported side effects assessed via a participant questionnaire.
Measured: up to 6 weeks postpartum
ACTS Burden Score
Treatment burden associated with assigned anticoagulant therapy, assessed using the ACTS Burden subscale. The subscale contains 5 items with a total score ranging from 5 to 25. Lower scores indicate lower perceived treatment burden and greater treatment satisfaction.
Measured: Up to 6 weeks postpartum
ACTS Benefit Score
Perceived benefit of assigned anticoagulant therapy, assessed using the Anti-Clot Treatment Scale (ACTS) Benefit subscale. The ACTS Benefit subscale consists of 3 items evaluating patient perception of treatment effectiveness and reassurance. Total scores range from 3 to 15. Higher scores indicate greater perceived treatment benefit.
Measured: Up to 6 weeks postpartum
Treatment Convenience Score
Participant-reported convenience of assigned anticoagulant therapy, assessed using a Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 represents "not convenient at all" and 10 represents "extremely convenient." Higher scores indicate greater treatment convenience.
Measured: Up to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ron Beloosesky MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ron Beloosesky MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716332
- Sponsor's protocol ID
- 0495-24RMB
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban Versus Enoxaparin for Thromboprophylaxis After Delivery
- ClinicalTrials.gov ID
- NCT07716332
- Acronym / sponsor ID
- 0495-24RMB
- Conditions
- Postpartum, DVT Prophylaxis
- Keywords
- apixaban, enoxaparin, vte prophylaxis, postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ron Beloosesky MDUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the use of oral apixaban to subcutaneous enoxaparin for venous thromboembolism (VTE) prophylaxis in postpartum women at high risk for VTE. The primary goal is to evaluate medication adherence rates and patient satisfaction with the treatment.
Detailed description
Venous thromboembolism (VTE) is a leading cause of pregnancy-related morbidity and mortality. Current guidelines recommend pharmacologic thromboprophylaxis with low-molecular-weight heparin (LMWH), such as enoxaparin, for postpartum women with increased risk factors. However, common patient complaints related to enoxaparin include injection site reaction, pain, bruising, bleeding, nausea, vomiting, and cost. Oral anticoagulation therapy, such as apixaban (an oral factor Xa inhibitor), could obviate many of these negative effects.This single-center, prospective, open-blinded randomized controlled trial aims to investigate the use of apixaban versus enoxaparin for VTE prophylaxis in the postpartum period. Eligible postpartum women (after vaginal or cesarean delivery) with high risk for VTE will be randomized in a 1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: ApixabanApixaban. 2.5 mg administered orally twice a day |
| Enoxaparin | Active comparator | Drug: EnoxaparinEnoxaparin. 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- After Vaginal or C/S delivery.
- Need prophylactic treatment in a preventive dose.
- Presence of one or more high risk factors: Active infection, IBD, Heart disease, Type 1 diabetes with nephropathy, IV drug user, Surgical operation in Postpartum period, Emergency cesarean section.
- OR presence of 2 low risk factors: Age > 35, post-partum hemorrhage > 1000 ml, Cesarean section, Hysterectomy, BMI > 30, Multiparity- Third birth or more, Active Smoking, Obstetric complications in current pregnancy (including preeclampsia, preterm birth before 37 weeks, active infection including chorioamnionitis, prolonged labor over 24 hours), Twin birth, Immobility, Large varicose veins, Stillbirth
Key exclusion criteria (13 listed)
- Breast feeding.
- Predispose to hypercoagulability
- Familial history of VTE.
- Antiphospholipid syndrome (APS).
- Prior VTE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: eliquisApixaban. 2.5 mg administered orally twice a day | Drug | Apixaban |
| EnoxaparinAlso: clexaneEnoxaparin 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day | Drug | Enoxaparin |
Primary outcome
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
Time frame: up to 6 weeks postpartum
Patient-reported treatment convenience assessed using a study-specific questionnaire. The primary measurement is an 11-point general convenience Visual Analog Scale (VAS) where patients rate the overall convenience of their assigned post-partum anticoagulant treatment (oral vs. subcutaneous) from 0 ("Not convenient at all") to 10 ("Very convenient"). Higher scores indicate a higher level of treatment convenience. The outcome also incorporates a categorical question evaluating whether the treatment was easy to take/receive (categorized as: Agree, Neutral, Disagree).
Medication Adherence Rate Assessed by Patient Self-Report
Time frame: Up to 6 weeks postpartum
Adherence to the prescribed thromboprophylaxis regimen, assessed via patient self-report within the study questionnaire. Adherence is evaluated through targeted categorical questions regarding compliance: (1) whether the patient faced difficulties remembering to take the medication, and (2) whether any dose was missed during the hospitalization period. Responses are categorized as "Agree," "Neutral," or "Disagree." The outcome will be reported as the percentage of patients who demonstrated adherence (i.e., no missed doses and no memory difficulties) versus non-adherent patients
Treatment-Related Pain Intensity Assessed by a Visual Analog Scale (VAS)
Time frame: Up to 6 weeks postpartum
Intensity of pain specifically associated with the administration of the assigned anticoagulant therapy. This is evaluated using an 11-point Visual Analog Scale (VAS) embedded in the questionnaire. Patients who report experiencing treatment-related pain rate its intensity on a scale ranging from 0 ("No pain at all") to 10 ("Unbearable pain"). Lower scores indicate lower pain levels and better treatment tolerance.
Patient Treatment Preference and Recommendation Assessed by Self-Report
Time frame: Up to 6 weeks postpartum
Patient preference for future short-term preventative treatment options based on their experience during the clinical trial. Patients select their preferred route of administration from three options: Oral tablets, Subcutaneous injections, or No preference. Additionally, the assessment includes a categorical question on whether the patient would recommend their assigned treatment to another person (Categorized as: Agree, Disagree, Do not know). Results will be presented as the proportion (%) of patients in each preference and recommendation category.
7 secondary outcomes
Incidence of Venous Thromboembolism (VTE)
Time frame: up to 6 weeks postpartum
Incidence of major bleeding and bleeding events
Time frame: up to 6 weeks postpartum
Decrease in hemoglobin values
Time frame: From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)
Incidence of adverse events
Time frame: up to 6 weeks postpartum
ACTS Burden Score
Time frame: Up to 6 weeks postpartum
ACTS Benefit Score
Time frame: Up to 6 weeks postpartum
Treatment Convenience Score
Time frame: Up to 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Apixaban and Enoxaparin in people with Postpartum and DVT Prophylaxis, run by Ron Beloosesky MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nira Gridish (+972503027855, n_gridish@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire (time frame: up to 6 weeks postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.