EUCTR2014-004249-29-GB进行中（未招募）1 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 - Dabigatran Presence in Breast Milk (DALMATION)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Women aged =18 years
- •Woman has had a vaginal birth (spontaneous or instrumental)
- •Minimum of 48 hours has passed after delivery of the baby/ removal of epidural catheter or spinal anaesthesia
- •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.
- •Hospital inpatient
- •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.
- •Decision has been confirmed by the woman to exclusively formula-feed her baby (including women who have since decided to stop breast-feeding their baby)
- •Midwife has confirmed the decision with the woman and has documented this in the Feeding Your Baby Booklet held in the medical notes.
- •Normal renal function test – results of the serum creatinine <90 micro mol/L.
- •Normal liver function tests – results of the serum ALT •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 non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, diclofenac, naproxen, indometnacin) for at least 3 days after taking the study treatment)
- •Participant has provided written informed consent for participation in the study before any study specific procedures take place.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Women who are planning to/are breastfeeding
- •Women who are planning to/giving their baby expressed breast milk
- •Women who are unsure of their decision to breast feed or formula feed
- •Women who are unable to provide written informed consent
- •LMWH thromboprophylaxis is indicated
- •Increased risk of bleeding for any reason
- •An increased tendency to bleed (inborn, of unknown cause or due to other medications)
- •Known contra-indications to dabigatran
- •On-going treatment with aspirin, NSAIDs or other drugs that affect haemostasis
- •Treatment with oral ketoconazole or itraconazole, medicines to treat fungal infections
- •Patients who have received an artificial heart valve, have had a heart attack or suffer an irregular heartbeat (including taking dronedarone)
- •Known impaired renal function (serum creatinine > 90 micro mol/L)
- •Known abnormal liver function tests (ALT > 40 IU/L)
- •Known hypersensitivity or allergy to dabigatran
- •Use of other investigational study drugs within 30 days prior to study entry
研究者
相似试验
已完成
2 期
Dabigatran Presence in Breast Milk (DALMATION)Topic: Children, Reproductive HealthSubtopic: Children (all Diagnoses), Reproductive Health & Childbirth (all Subtopics)Disease: All Diseases, Reproductive Health & ChildbirthPregnancy and ChildbirthPreventing deep vein thrombosis after childbirthISRCTN87845776ewcastle upon Tyne Hospitals NHS Foundation Trust2
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