ISRCTN87845776已完成2 期
An Open Label, Non-Randomised, Phase II study to Determine if Dabigatran and its Metabolites are Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 2 人开始时间: 2016年3月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women aged 18 years and over
- •2. Woman has had a vaginal birth (spontaneous or instrumental)
- •3. Minimum of 48 hours has passed after delivery of the baby/removal of epidural catheter or spinal anaesthesia
- •4. Minimum of 24 hours has passed after the decision has been made and documented in the notes to stop breast feeding the baby after starting/trying to start
- •5. Hospital inpatient
- •6. Woman has been offered the opportunity to have a discussion at delivery and in the immediate postnatal period in relation to their feeding choices using the Feeding Your Baby booklet
- •7. Decision has been confirmed by the woman to exclusively formulafeed her baby (including women who have since decided to stop breastfeeding their baby)
- •8. Midwife has confirmed the decision with the woman and has documented this in the Feeding Your Baby Booklet held in the medical notes.
- •9. Normal renal function test – results of the serum creatinine <90 micro mol/L
- •10. Normal liver function tests – results of the serum ALT 11. Not taking any medication except paracetamol and / or dihydrocodeine. Women who have been given ibuprofen for pain relief after delivery can be included at least 24 hours after the last dose. Women will be advised not to take nonsteroidal antiinflammatory drugs (aspirin, ibuprofen, diclofenac, naproxen, indometnacin) for at least 3 days after taking the study treatment)
- •12. Participant has provided written informed consent for participation in the study before any study specific procedures take place
排除标准
- •1. Women who are planning to/are breastfeeding
- •2. Women who are planning to/giving their baby expressed breast milk
- •3. Women who are unsure of their decision to breast feed or formula feed
- •4. Women who are unable to provide written informed consent
- •5. LMWH thromboprophylaxis is indicated
- •6. Increased risk of bleeding for any reason
- •7. An increased tendency to bleed (inborn, of unknown cause or due to other medications)
- •8. Known contraindications to dabigatran
- •9. Ongoing treatment with aspirin, NSAIDs or other drugs that affect haemostasis
- •10. Treatment with oral ketoconazole or itraconazole, medicines to treat fungal infections
- •11. Patients who have received an artificial heart valve, have had a heart attack or suffer an irregular heartbeat (including taking dronedarone)
- •12. Known impaired renal function (serum creatinine > 90 micro mol/L)
- •13. Known abnormal liver function tests (ALT > 40 IU/L)
- •14. Known hypersensitivity or allergy to dabigatran
- •15. Use of other investigational study drugs within 30 days prior to study entry
研究者
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