Health Condition 1: O30-O48- Maternal care related to the fetus and amniotic cavity and possible delivery problems
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
SRM Medical College and Research Insitute
Eligibility
Inclusion criteria
Inclusion criteria: (a) Lactating female Subjects aged 18 to 35 years having undergone term live deliveries (Preferably normal deliveries) where Acetaminophen is given as a part of post-natal routine treatment. (b) Subject has undergone training on handling of milk pump and meets requirement (c) Subjects willing to provide upto 4 mL milk sample at requested time points on second post natal day and a total of upto 24mL of milk samples across 6 scheduled time points. (d) Subjects willing to accept the informed consent in the study.
Exclusion criteria
Exclusion criteria: (a) Subject having any significant medical history that might interfere with the conduct of the study (b) Deliveries where any co-morbid conditions could impact the study outcomes as identified by the Medical Investigator (c) Cases where medical investigator confirms that milk supply is inadequate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prediction of Acetaminophen concentration using PBPK model in lactating females using inputs from Clinical samplesTimepoint: Prediction of Acetaminophen concentration based on samples collected at time points 00.20 Hr, 00.40Hr, 01.00Hr, 01.50Hr, 02.00Hr and 04.00 Hrs post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Establish the amount of Acetaminophen that is transferred from the lactating mother to infant based on calculationsTimepoint: To establish the amount based on volume of milk feeded to the infant during the collected time & extrapolate to calculate daily dose amount | — |
Countries
India
Contacts
Public ContactDr Mohammed Sulaiman Sait
SRM Institute of Science and Technology
Outcome results
None listed