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

Randomized double-blind comparison of phenylephrine and norepinephrine for treatment of post-spinal hypotension in parturients with fetal compromise

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016518

Enrollment

100

Registered

2018-12-03

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: O469- Antepartum hemorrhage, unspecified Health Condition 2: O68- Labor and delivery complicated byabnormality of fetal acid-base balance Health Condition 3: O410- Oligohydramnios

Interventions

Intervention1: Norepinephrine group: Patients will receive intravenous norepinephrine 8 microg for treatment of each episode of hypotension till the time of delivery Control Intervention1: Phenylephri

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy females with singleton pregnancy undergoing emergency caesarean section for potential fetal compromise under spinal anaesthesia 2. Non-reassuring fetal heart rate (FHR) status i.e. FHR more than 160 or less than 100 bpm 3. FHR deceleration(variable or late), which fails to recover after uterine contraction has passed (type 2 dips) 4. Meconium stained liquor with FHR abnormality or thick meconium stained liquor 5. Cord prolapse 6. Intra-uterine growth restriction 7. Oligohydramnios 8. Antepartum haemorrhage 9. Dystocia 10. Postmaturity 11. Prematurity

Exclusion criteria

Exclusion criteria: 1. Maternal complications e.g. pre-eclampsia, 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, autonomic neuropathy, spinal deformities, other neurological diseases, hypovolemia due to any cause 5. Maternal baseline SBP less than 100 mmHg 6. Severely compromised fetus requiring immediate administration of general anaesthesia to mother 7. Patients on monoamine oxidase inhibitors or tricyclic antidepressants 8. History suggestive of mesenteric or peripheral vascular thrombosis

Design outcomes

Primary

Measure	Time frame
â?¢ Umbilical artery pHTimepoint: â?¢Time of delivery of baby	—

Secondary

Measure	Time frame
â?¢ APGAR scores at 1 and 5 minutes â?¢ Incidence of fetal acidosis, defined as umbilical artery pH less than 7.20 â?¢ Number of neonates requiring admission to neonatal intensive care unit with their duration of stay â?¢ Total dose of vasopressor given â?¢ Number of episodes of hypotension â?¢ Incidence of bradycardia/ tachycardia/ arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications Timepoint: Till the time of delivery of baby	—

Measure

Time frame

â?¢ APGAR scores at 1 and 5 minutes â?¢ Incidence of fetal acidosis, defined as umbilical artery pH less than 7.20 â?¢ Number of neonates requiring admission to neonatal intensive care unit with their duration of stay â?¢ Total dose of vasopressor given â?¢ Number of episodes of hypotension â?¢ Incidence of bradycardia/ tachycardia/ arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications Timepoint: Till the time of delivery of baby

—

Countries

India

Contacts

Public ContactDr Neelima Bambode

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 4, 2026