A Study to Determine if Dabigatran is Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers.
- Conditions
- Future use for VTE prophylaxis.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2014-004249-29-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to determine if dabigatran and its metabolites are detectable in breast milk following oral administration to non-breast feeding mothers. <br><br>;Secondary Objective: The secondary objective is to determine dabigatran pharmacokinetics (Tmax, Cmax, t1/2, AUC) in maternal plasma and breast milk (if dabigatran is detectable in breast milk). <br>;Primary end point(s): To determine if Dabigatran is detectable in plasma and breast milk after it has been ingested by the mother. ;Timepoint(s) of evaluation of this end point: This will be measured at 0,1,2,5,7,10 hours after swallowing two 110mg capsules of <br>dabigatran.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): If Dabigatran is detected:<br><br>Time course of dabigatran concentration in breast milk.<br><br>Time course of dabigatran concentration in maternal plasma.<br>;Timepoint(s) of evaluation of this end point: This will be measured across the 0,1,2,5,7,10 hours after swallowing two 110mg capsules of dabigatran.