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Comparison of two medicines i.e. phenylephrine and norepinephrine for increasing blood pressure during caesarean delivery under spinal anaesthesia in patients with preeclampsia

Randomized double-blind comparison of phenylephrine and norepinephrine for management of post-spinal hypotension in preeclampsia patients undergoing caesarean section

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016478
Enrollment
86
Registered
2018-11-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O149- Unspecified pre-eclampsia

Interventions

Intervention1: Norepinephrine group: Patients will receive norepinephrine 4 microg intravenously for treatment of each episode of hypotension till the time of delivery Control Intervention1: Phenyleph

Sponsors

University College of Medical Sciences and Guru Teg Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preeclamptic females with singleton pregnancy undergoing caesarean section under spinal anaesthesia 2. Preeclampsia diagnosed as BP > 140/90 mmHg on two or more occasions at least 4 hrs apart and proteinuria > 300 mg/ 24 hrs or > 1+ dipstick test

Exclusion criteria

Exclusion criteria: 1. 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 e.g. infection in lumbar area, coagulation abnormalities, platelet count 5. Severe fetal distress or other conditions requiring immediate induction of general anaesthesia 6. Patients on monoamine oxidase inhibitors or tricyclic antidepressants 7. History suggestive of mesenteric or peripheral vascular thrombosis

Design outcomes

Primary

MeasureTime frame
Umbilical artery pHTimepoint: Time of delivery of baby

Secondary

MeasureTime frame
1. APGAR scores at 1 and 5 minutes 2. Incidence of fetal acidosis, defined as umbilical artery pH 7.20 3. Number of vasopressor boluses given 4. Number of episodes of hypotension 5. Incidence of tachycardia/bradycardia/arrhythmias/hypertension 6. Incidence of nausea, vomiting, dizziness or any other complication Timepoint: Till the time of delivery of baby

Countries

India

Contacts

Public ContactDr Lakshmi R

University College of Medical Sciences and Guru Teg Bahadur Hospital

medhamohta@gmail.com919868399626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 16, 2026