CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
Amino acid solution +1 moredrug
Likely dose
Ringer's lactate solution 200 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02575170
NCT02575170N/ACompleted

Intravenous Amino Acid Infusion in Mothers Before and During Cesarean Delivery: Effects on Maternal and Neonatal Temperature

B.P. Koirala Institute of Health Sciences·interventional·Posted Oct 14, 2015·Updated Mar 15, 2019

In Brief

A clinical study evaluating Amino acid solution and Ringer's lactate solution for Hypothermia. Completed, enrolled 76 participants across 1 site.

Detailed Summary

Introduction: Intravenous infusion of amino acids during cesarean delivery in mothers and neonates improves neonatal growth. Amino acid before and during anesthesia also prevents hypothermia and associated untoward effects. Method: After ethical approval, this prospective randomized double blind controlled study is being conducted in the university hospital of BPKIHS. Seventy six parturients (ASA 1 \& 2) undergoing cesarean delivery without fetal distress, intrauterine growth retardation, congenital malformation or premature labor will be enrolled. For a period starting from approximately one hour prior to spinal anesthesia, Group 1 and Group 2 patients will receive 200 ml of amino acid and lactated ringers solution respectively at 2 ml/kg/hr. The ambient operating room temperature will be maintained near 23º C. No heating methods will be applied apart from covering with a blanket. Primary outcome measure will be neonatal rectal temperature at 0, 5 and 10 min after birth. Secondary outcome measures will be APGAR scores and suckling reflex in the newborn, change in rectal temperature relative to baseline and discomfort related to cold sensation in the mother and the occurrence of shivering both in the mother and newborn.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypothermia
CountriesNepal
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 14, 2015
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.7 years ago

Interventions

Amino acid solutiondrug

a balanced mixture of 18 pure crystalline amino acids, eight of which are essential amino acids

Ringer's lactate solutiondrug

200 ml of Ringer's lactate solution