MedTrace Logo

Amino Acid Infusion in Mothers Before and During Cesarean Delivery

NCT02575170 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-03-15

No results posted yet for this study

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.

Conditions

  • Hypothermia

Interventions

DRUG

Amino acid solution

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

DRUG

Ringer's lactate solution

200 ml of Ringer's lactate solution

Sponsors & Collaborators

  • B.P. Koirala Institute of Health Sciences

    lead OTHER

Principal Investigators

  • Krishna Pokharel, MD · B.P. Koirala Institute of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Nepal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575170 on ClinicalTrials.gov