Calculation of the dose of the medicine, phenylephrine, for correcting fall in blood pressure during caesarean delivery under spinal anaesthesia in patients with preeclampsia

Calculation of effective dose of phenylephrine bolus for treatment of post-spinal hypotension in preeclamptic patients undergoing caesarean section- A non randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031073

Enrollment

Registered

2021-02-08

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication Health Condition 2: O149- Unspecified pre-eclampsia

Interventions

Intervention1: Preeclamptic group: Postspinal hypotension will be treated with phenylephrine, the dose of which will be decided according to the response in the previous patients Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: For Preeclamptic group 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 For Normotensive group Healthy females with term uncomplicated singleton pregnancy undergoing elective caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 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. Maternal baseline systolic blood pressure less than 100 mmHg

Design outcomes

Primary

Measure	Time frame
ED95 and ED50 of phenylephrine bolus for treatment of postspinal hypotension in preeclamptic patientsTimepoint: One minute after phenylephrine administration for correction of postspinal hypotension	—

Secondary

Measure	Time frame
1. ED95 and ED50 of phenylephrine bolus for treatment of postspinal hypotension in normotensive patients 2. Proportionate reduction in effective dose in preeclamptic patients compared to normotensive patients 3. Any maternal complicationsTimepoint: One minute after phenylephrine administration for correction of postspinal hypotension	—

Countries

India

Contacts

Public ContactDr Sarita Kumari

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