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Study of three doses of phenylephrine,a medicine to increase BP, in pregnant patients having high BP disease, and undergoing caesarean delivery

Phase 4
Conditions
Health Condition 1: O149- Unspecified pre-eclampsia
Registration Number
CTRI/2023/08/055926
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

1. Preeclamptic females with singleton pregnancy undergoing caesarean section under spinal

anaesthesia

2. Preeclampsia diagnosed as BP more than 140 mmHg systolic or 90 mmHg diastolic on two or more occasions at least 4 hrs apart and proteinuria more than 300 mg in 24 hrs or more than 1+ dipstick test; or signs or symptoms of endorgan

involvement in the absence of proteinuria (including persistent epigastric or right

upper quadrant pain, persistent cerebral symptoms, fetal growth restriction,thrombocytopenia or elevated serum liver enzymes)

Exclusion Criteria

1. History suggestive of maternal complications other than preeclampsia e.g. chronic

hypertension, other cardiovascular disease, cerebrovascular disease

2. Multiple gestation

3. Known fetal abnormality

4. Patients with absolute or relative contra-indications for spinal anaesthesia

5. Severe fetal distress or other conditions requiring immediate induction of general

anaesthesia

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of physician interventions required to maintain systolic blood pressure near baseline valueTimepoint: Till the time of delivery
Secondary Outcome Measures
NameTimeMethod
1. Incidence of reactive hypertension, hypotension & bradycardia <br/ ><br>2. Total phenylephrine requirement <br/ ><br>3. Fetal acid-base status <br/ ><br>4. Incidence of fetal acidosis, defined as umbilical artery pH less than 7.20 <br/ ><br>5. Neonatal Apgar scores at 1 and 5 min <br/ ><br>6. Incidence of nausea, vomiting, dizziness or any other maternal complications <br/ ><br>Timepoint: Till the time of delivery
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