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Comparison of two medications used to increase blood pressure i.e. phenylephrine and norepinephrine for prevention of fall in blood pressure during caesarean delivery under spinal anaesthesia in patients with babies in compromised situatio

Phase 4
Conditions
Health Condition 1: O76- Abnormality in fetal heart rate and rhythm complicating labor and deliveryHealth Condition 2: O68- Labor and delivery complicated byabnormality of fetal acid-base balanceHealth Condition 3: O669- Obstructed labor, unspecifiedHealth Condition 4: O601- Preterm labor with preterm delivery
Registration Number
CTRI/2021/02/031048
Lead Sponsor
niversity College of Medical Sciences and Guru Teg Bahadur Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

•Healthy females with singleton pregnancy undergoing caesarean section for potential fetal compromise under spinal anaesthesia

•Non-reassuring fetal heart rate (FHR) status i.e. FHR >160 or <100 bpm or abnormal FHR ( > 180 bpm) (As per the RCOG guidelines 2018)

•FHR deceleration (variable or late), which fails to recover after uterine contraction has passed (type 2 dips)

•Meconium stained liquor with FHR abnormality or thick meconium stained liquor

•Intra-uterine growth restriction

•Oligohydramnios

•Antepartum haemorrhage

•Dystocia

•Postmaturity

•Prematurity

Exclusion Criteria

•Maternal complications e.g. pre-eclampsia, cardiovascular disease, cerebrovascular disease

•Multiple gestation

•Known fetal abnormality

•Patients with absolute or relative contra-indications for spinal anaesthesia e.g. infection in lumbar area, coagulation abnormalities, autonomic neuropathy, spinal deformities, other neurological diseases, hypovolemia due to any cause

•Maternal baseline SBP less than 100 mmHg

•Severely compromised fetus requiring immediate administration of general anaesthesia to mother

•Patients on monoamine oxidase inhibitors or tricyclic antidepressants

•History suggestive of mesenteric or peripheral vascular thrombosis

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
mbilical artery pHTimepoint: Time of delivery of baby
Secondary Outcome Measures
NameTimeMethod
â?¢Apgar scores at 1 and 5 minutes <br/ ><br>â?¢Incidence of fetal acidosis, defined as umbilical artery pH 7.20 <br/ ><br>â?¢Total dose of vasopressor given <br/ ><br>â?¢Duration of exposure to vasopressors <br/ ><br>â?¢Number of episodes of hypotension/hypertension <br/ ><br>â?¢Incidence of bradycardia/ tachycardia/ arrhythmias <br/ ><br>â?¢Incidence of nausea, vomiting, dizziness or any other complications <br/ ><br> <br/ ><br>Timepoint: Time of delivery of baby
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