Amino Acid Infusion in Mothers Before and During Cesarean Delivery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02575170
• Date of registration: 04/10/2015
• Prospective Registration: No
• Primary sponsor: B.P. Koirala Institute of Health Sciences
• Public title: Amino Acid Infusion in Mothers Before and During Cesarean Delivery
• Scientific title: Intravenous Amino Acid Infusion in Mothers Before and During Cesarean Delivery: Effects on Maternal and Neonatal Temperature
• Date of first enrolment: June 2013
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02575170
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Nepal

Contacts

• Name: Krishna Pokharel, MD
• Affiliation: B.P. Koirala Institute of Health Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- Parturients belonging to American Society of Anesthesiologists physical status I and
II scheduled for elective cesarean delivery were enrolled.

Exclusion Criteria:

- Pregnancy with fetal distress, intrauterine growth retardation, congenital
malformation or premature labor were excluded.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Hypothermia

Intervention(s)

Drug: Amino acid solution

Drug: Ringer's lactate solution

Primary Outcome(s)

neonatal rectal temperature [Time Frame: 0 min after delivery]

neonatal rectal temperature [Time Frame: 5 min after delivery]

neonatal rectal temperature [Time Frame: 10 min after delivery]

Secondary Outcome(s)

length of hospital stay of mother [Time Frame: up to 72 hours]

number of neonates who developed shivering [Time Frame: during the first 10 min after birth]

change in maternal rectal temperature compared to baseline [Time Frame: before infusion (baseline) and 1 hour]

number of mothers who developed shivering [Time Frame: intraoperative period during spinal anesthesia]

number of newborn with adequate suckling reflex [Time Frame: 10 min after birth]

length of hospital stay of newborn [Time Frame: up to 72 hours]

scale assessing the discomfort related to cold sensation in mother [Time Frame: intraoperative period during spinal anesthesia]

APGAR score of newborn [Time Frame: 0 min, 5 min, 10 min after birth]

change in maternal rectal temperature compared to baseline [Time Frame: before infusion (baseline) and at the end of infusion of 200 ml of study solution]

change in maternal rectal temperature compared to baseline [Time Frame: before infusion (baseline) and at one hour after spinal block]

maternal rectal temperature [Time Frame: at the time of delivery during intraoperative period (usually within 30 minutes)]

Secondary ID(s)

599/068/069

Source(s) of Monetary Support

Please refer to primary and secondary sponsors