ISRCTN87845776
Completed
Phase 2
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 sites2 target enrollmentMarch 9, 2016
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Topic: Children, Reproductive Health
- Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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