Apixaban Versus Enoxaparin for Postpartum Venous Thromboembolism Prophylaxis
2026년 7월 20일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
150
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Nira Gridish
- 전화번호: +972503027855
- 이메일: n_gridish@rambam.health.gov.il
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Apixaban
Apixaban.
2.5 mg administered orally twice a day
|
Apixaban.
2.5 mg administered orally twice a day
다른 이름들:
|
|
활성 비교기: 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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
General Treatment Convenience Assessed by a Study-Specific Patient Satisfaction Questionnaire
기간: 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
기간: 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)
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Venous Thromboembolism (VTE)
기간: up to 6 weeks postpartum
|
Occurrence of VTE event
|
up to 6 weeks postpartum
|
|
Incidence of major bleeding and bleeding events
기간: 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
기간: 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
기간: up to 6 weeks postpartum
|
Patient-reported side effects assessed via a participant questionnaire.
|
up to 6 weeks postpartum
|
|
ACTS Burden Score
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 4월 1일
연구 등록 날짜
최초 제출
2026년 3월 22일
QC 기준을 충족하는 최초 제출
2026년 7월 20일
처음 게시됨 (실제)
2026년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 20일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0495-24RMB
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .