Transfer of parecoxib into breast milk; a study of post-operative use following caesarean section.

Not Applicable

• Conditions: Parecoxib transfer into breast milk; Reproductive Health and Childbirth - Breast feeding

• Registration Number: ACTRN12607000396426
• Lead Sponsor: Michael Paech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Women post caesarean section requiring conventional non steroidal inflammatory drugss for analgesia on day 3 or 4 following delivery.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative Infant dose of parecoxib and valdecoxib (active metabolite) - via pharmacokinetic analysis.<br>[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 Measures

Name	Time	Method
Infant wellbeing - by means of a neuroadaptive capacity score - range 0-40<br>[Zero and 24 hours post dose.]