Epidural Pethidine after Caesarean Section. A pilot study of initiation of lactation, plasma and milk levels of pethidine and norpethidine and the behaviour of breast-fed infants.

Not Applicable

Completed

• Conditions: Initiation and establishment of lactation after caesarean and vaginal delivery; Breastfeeding behaviour in the infant; Reproductive Health and Childbirth - Breast feeding; Anaesthesiology - Pain management

• Registration Number: ACTRN12609000614291
• Lead Sponsor: Dr Yasir Al-Tamimi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

For all:
American Society of Anesthesiologists (ASA) Classification I and II
18 years and over
For study group:
Mothers (and their infants) delivered via elective caesarean at term (37 weeks gestation or more) and preference for pethidine PCEA postoperatively
For comparison groups:
Mothers (and their infants) delivered via elective caesarean not using pethidine PCEA postoperatively
Mothers (and their infants) delivered vaginally who were not exposed to systemic or epidural pethidine during labour

Exclusion Criteria

Non-elective caesarean delivery
Preoperative opioid use
Multiple pregnancies
Maternal diabetes or impairment of glucose regulation
Abnormal renal function or severe pre-eclampsia
Intolerance or allergy to pethidine
Change to alternative analgesia to pethidine within 24 hours postoperatively
Inability to provide adequate breast milk samples
Neonates requiring admission to intensive care

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Initiation and establishment of lactation: determined by measuring the change in concentration of lactose, sodium, total protein and citrate in small samples of colostrum and breast milk[Day 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, and 10 days postpartum];24 hour milk production: measured by the test weighing method[Weighing at the end of day 5 and again on day 10];Breast feeding behaviour: assessed by ultrasound and intraoral pressure[On Day 2 and Day 10 postpartum]

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of pethidine and norpethidine[At and 6 hours after cessation of pethidine PCEA postoperatively or at 48 hours if still using pethidine PCEA];Milk concentrations of pethidine and norpethidine[At and 6 hours after cessation of pethidine PCEA postoperatively or at 48 hours if still using pethidine PCEA];Plasma concentrations of pethidine and norpethidine postoperatively among breast-fed infants exposed to maternal pethidine[At 48 hours postoperatively];Neurobehavioural scores (neonatal adaptive capcity score or NACS) and evaluation of breast-feeding behaviour with LATCH-R scores (Latch, Audible swallow, Type of nipple, Comfort and nipple state, Hold: mothers ability to position, and Responsiveness and confidence)[Assessed on Day 2 and Day 10 postpartum]