Study of three doses of phenylephrine,a medicine to increase BP, in pregnant patients having high BP disease, and undergoing caesarean delivery

Comparison of three manually controlled prophylactic infusion doses of phenylephrine in preeclampsia patients undergoing caesarean section under spinal anaesthesia – A randomised double blind trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/055926

Enrollment

102

Registered

2023-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Phenylephrine 25: Patients will receive prophylactic phenylephrine infusion beginning at a rate of 25 microg per min and titrated according to systolic blood pressure Intervention2: Phe

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preeclamptic females with singleton pregnancy undergoing caesarean section under spinal anaesthesia 2. Preeclampsia diagnosed as BP more than 140 mmHg systolic or 90 mmHg diastolic on two or more occasions at least 4 hrs apart and proteinuria more than 300 mg in 24 hrs or more than 1+ dipstick test; or signs or symptoms of endorgan involvement in the absence of proteinuria (including persistent epigastric or right upper quadrant pain, persistent cerebral symptoms, fetal growth restriction,thrombocytopenia or elevated serum liver enzymes)

Exclusion criteria

Exclusion criteria: 1. History suggestive of 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 5. Severe fetal distress or other conditions requiring immediate induction of general anaesthesia

Design outcomes

Primary

Measure	Time frame
Number of physician interventions required to maintain systolic blood pressure near baseline valueTimepoint: Till the time of delivery	—

Secondary

Measure	Time frame
1. Incidence of reactive hypertension, hypotension & bradycardia 2. Total phenylephrine requirement 3. Fetal acid-base status 4. Incidence of fetal acidosis, defined as umbilical artery pH less than 7.20 5. Neonatal Apgar scores at 1 and 5 min 6. Incidence of nausea, vomiting, dizziness or any other maternal complications Timepoint: Till the time of delivery	—

Countries

India

Contacts

Public ContactDr Aditi Jain

University College of Medical Sciences and Guru Teg Bahadur Hospital

medhamohta@hotmail.com9625900626

Outcome results

None listed

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