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 situation

Comparison of prophylactic infusions of phenylephrine and norepinephrine in parturients with fetal compromise undergoing caesarean section: a randomised double blind study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031048

Enrollment

436

Registered

2021-02-05

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: O76- Abnormality in fetal heart rate and rhythm complicating labor and delivery Health Condition 2: O68- Labor and delivery complicated byabnormality of fetal acid-base balance Health Condition 3: O669- Obstructed labor, unspecified Health Condition 4: O601- Preterm labor with preterm delivery

Interventions

Intervention1: Norepinephrine group: Prophylactic intravenous infusion of norepinephrine 2 microg per min will be started after spinal injection using an infusion pump Control Intervention1: Phenylep

Eligibility

Inclusion criteria

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 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

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

Design outcomes

Secondary

Measure	Time frame
â?¢ Apgar scores at 1 and 5 minutes â?¢ Incidence of fetal acidosis, defined as umbilical artery pH 7.20 â?¢ Total dose of vasopressor given â?¢ Duration of exposure to vasopressors â?¢ Number of episodes of hypotension/hypertension â?¢ Incidence of bradycardia/ tachycardia/ arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications Timepoint: 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 7.20 â?¢ Total dose of vasopressor given â?¢ Duration of exposure to vasopressors â?¢ Number of episodes of hypotension/hypertension â?¢ Incidence of bradycardia/ tachycardia/ arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications Timepoint: Time of delivery of baby

—

Primary

Measure	Time frame
Umbilical artery pHTimepoint: Time of delivery of baby	—

Countries

India

Contacts

Public ContactDr Pratibha

University College of Medical Sciences and Guru Teg Bahadur Hospital

medhamohta@gmail.com9868399626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026