Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis
2026年7月20日 更新者：Ron Beloosesky MD
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
150
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nira Gridish
- 電話番号：+972503027855
- メール：n_gridish@rambam.health.gov.il
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Breast feeding.
- Predispose to hypercoagulability
- Familial history of VTE.
- Antiphospholipid syndrome (APS).
- Prior VTE.
- Anticoagulant treatment before or during pregnancy.
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Apixaban
Apixaban.
2.5 mg administered orally twice a day
|
Apixaban.
2.5 mg administered orally twice a day
他の名前：
|
|
アクティブコンパレータ：Enoxaparin
Enoxaparin. 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day
|
Enoxaparin 40 mg (or 60 mg for weight > 91 kg) administered subcutaneously once a day
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
時間枠：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).
|
up to 6 weeks postpartum
|
|
Medication Adherence Rate Assessed by Patient Self-Report
時間枠：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
|
Up to 6 weeks postpartum
|
|
Treatment-Related Pain Intensity Assessed by a Visual Analog Scale (VAS)
時間枠：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.
|
Up to 6 weeks postpartum
|
|
Patient Treatment Preference and Recommendation Assessed by Self-Report
時間枠：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.
|
Up to 6 weeks postpartum
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Venous Thromboembolism (VTE)
時間枠：up to 6 weeks postpartum
|
Occurrence of VTE event
|
up to 6 weeks postpartum
|
|
Incidence of major bleeding and bleeding events
時間枠：up to 6 weeks postpartum
|
Major bleeding and bleeding events defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria.
|
up to 6 weeks postpartum
|
|
Decrease in hemoglobin values
時間枠：From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)
|
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.
|
From baseline (admission to labor and delivery unit) up to the day of postpartum discharge (typically 2 to 5 days)
|
|
Incidence of adverse events
時間枠：up to 6 weeks postpartum
|
Patient-reported side effects assessed via a participant questionnaire.
|
up to 6 weeks postpartum
|
|
ACTS Burden Score
時間枠：Up to 6 weeks postpartum
|
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.
|
Up to 6 weeks postpartum
|
|
ACTS Benefit Score
時間枠：Up to 6 weeks postpartum
|
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.
|
Up to 6 weeks postpartum
|
|
Treatment Convenience Score
時間枠：Up to 6 weeks postpartum
|
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.
|
Up to 6 weeks postpartum
|
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スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年3月22日
QC基準を満たした最初の提出物
2026年7月20日
最初の投稿 (実際)
2026年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月20日
最終確認日
2026年7月1日
詳しくは
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