A clinical trial to study the effect of ephedrine and phenylephrine for treatment of fall in blood pressure during spinal anaesthesia in patients undergoing emergency caesarean section for compromised fetus

Randomized double-blind comparison of ephedrine and phenylephrine for management of post-spinal hypotension in mothers with fetal compromise

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/11/003150

Enrollment

106

Registered

2012-11-27

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: null- Spinal anaesthesia induced hypotension

Interventions

Intervention1: Phenylephrine 100 microg IV: Phenylephrine 100 microg will be injected IV whenever maternal systolic BP is less than 100 mmHg Control Intervention1: Ephedrine 8 mg IV: Ephedrine 8 mg wi

Eligibility

Inclusion criteria

Inclusion criteria: • ASA I/II females with singleton pregnancy undergoing emergency caesarean section for fetal compromise under spinal anaesthesia • Non-reassuring fetal heart rate (FHR) status i.e.FHR >170 or • FHR deceleration 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 • Cord prolapse • Oligohydramnios • Abruptio placentae • Post-maturity • Pre-maturity

Exclusion criteria

Exclusion criteria: • Maternal complications e.g. pregnancy induced hypertension, 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 systolic BP less than 100 mmHg

Design outcomes

Primary

Measure	Time frame
â?¢ Umbilical artery pHTimepoint: At the time of delivery	—

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 admitted to neonatal ICU with their duration of stay â?¢ Total dose of vasopressor given â?¢ Number of episodes of hypotension â?¢ Incidence of tachycardia/ bradycardia/arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications Timepoint: After delivery (For APGAR scores, incidence of fetal acidosis, neonates admitted to ICU) Till the time of delivery (For dose of vasopressor, episodes of hypotension, incidence of tachycardia/ bradycardia/ arrhythmia, incidence of nausea/vomiting/other complications)	—

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 admitted to neonatal ICU with their duration of stay â?¢ Total dose of vasopressor given â?¢ Number of episodes of hypotension â?¢ Incidence of tachycardia/ bradycardia/arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications Timepoint: After delivery (For APGAR scores, incidence of fetal acidosis, neonates admitted to ICU) Till the time of delivery (For dose of vasopressor, episodes of hypotension, incidence of tachycardia/ bradycardia/ arrhythmia, incidence of nausea/vomiting/other complications)

—

Countries

India

Contacts

Public ContactDr Medha Mohta

University College of Medical Sciences and Guru Teg Bahadur Hospital

drmeghaaggarwal@gmail.com

Outcome results

None listed

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