Dabigatran Presence in Breast Milk (DALMATION)

Phase 2

Completed

• Conditions: Topic: Children, Reproductive Health; Subtopic: Children (all Diagnoses), Reproductive Health & Childbirth (all Subtopics); Disease: All Diseases, Reproductive Health & Childbirth; Pregnancy and Childbirth; Preventing deep vein thrombosis after childbirth

• Registration Number: ISRCTN87845776
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Study Completion: 2016-08-31
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2

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)
12. Participant has provided written informed consent for participation in the study before any study specific procedures take place

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dabigatran presence in plasma and breast milk is measured at baseline, 1, 2, 3, 5, 7, 10 hours.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Presence of dabigatran metabolites in breast milk is measured at baseline, 1, 2, 3, 5, 7, 10 hours<br> 2. Time course of dabigatran concentration in breast milk is measured at baseline, 1, 2, 3, 5, 7, 10 hours<br> 3. Time course of dabigatran concentration in maternal plasma is measured at baseline, 1, 2, 3, 5, 7, 10 hours<br>