Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000396426
Ethics application status
Approved
Date submitted
30/07/2007
Date registered
2/08/2007
Date last updated
2/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Transfer of parecoxib into breast milk; a study of post-operative use following caesarean section.
Scientific title
A study of post-operative precoxib following caesarean section to evaluate the transfer of parecoxib into breast milk.
Universal Trial Number (UTN)
Trial acronym
TROPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parecoxib transfer into breast milk 2200 0
Condition category
Condition code
Reproductive Health and Childbirth 2295 2295 0 0
Breast feeding

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Single dose of parecoxib 40mg intravenously on day 3 or 4 post caesarean section administered to women receiving a conventional non steroidal anti inflammatory drug for routine post-operative analgesia.
Four breast milk (colustrum) samples will be taken over the 24 hours following the dose and a single maternal blood sample approx 6-8 hours post dose (coinciding with one of the breast milk samples).
Intervention code [1] 1915 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 3185 0
Relative Infant dose of parecoxib and valdecoxib (active metabolite) - via pharmacokinetic analysis.
Timepoint [1] 3185 0
Four breast milk samples will be taken during the 24 hours after the parecoxib dose ( randomised sample times - at zero, 1, 2, 4, 6, 8, 12, and 24 hours post dose - but one to coincide with the blood sample taken at 6-8 hours post dose).
Secondary outcome [1] 5311 0
Infant wellbeing - by means of a neuroadaptive capacity score - range 0-40
Timepoint [1] 5311 0
Zero and 24 hours post dose.

Eligibility
Key inclusion criteria
Women post caesarean section requiring conventional non steroidal inflammatory drugss for analgesia on day 3 or 4 following delivery.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known hypersensitivity to parecoxib or allergy to sulphonamidesrenal dysfunctionknown past or current peptic ulcer disease or gastro-oesophageal refluxhypertensionNSAID or aspirin induced asthmaischaemic heart disease or cerebrovascular diseasewomen with a preterm infant or an infant requiring care in the neonatal nursery< 18 years of age.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2458 0
Government body
Name [1] 2458 0
Australia and New Zealand College of Anaesthetists Project grant
Country [1] 2458 0
Primary sponsor type
Individual
Name
Michael Paech
Address
Country
Secondary sponsor category [1] 2231 0
None
Name [1] 2231 0
nil
Address [1] 2231 0
Country [1] 2231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4322 0
King Edward Memorial Hospital for Women
Ethics committee address [1] 4322 0
Ethics committee country [1] 4322 0
Date submitted for ethics approval [1] 4322 0
Approval date [1] 4322 0
Ethics approval number [1] 4322 0

Summary
Brief summary
This study aims to determine the extent of transfer of parecoxib into human breast milk. It is hoped to demonstate that the infant doses of parecoxib received in breast milk of women in early stage lactation and receiving this drug for pain control are not sufficient to cause concern about adverse effects in the neonate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27729 0
Address 27729 0
Country 27729 0
Phone 27729 0
Fax 27729 0
Email 27729 0
Contact person for public queries
Name 11104 0
Michael Paech
Address 11104 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco WA 6008
Country 11104 0
Australia
Phone 11104 0
08 9340 2222
Fax 11104 0
Email 11104 0
[email protected]
Contact person for scientific queries
Name 2032 0
Melanie Thew
Address 2032 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco WA 6008
Country 2032 0
Australia
Phone 2032 0
08 9340 2222
Fax 2032 0
Email 2032 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.