FindTrial
Sign In

A study to compare different infusion plans for preventing low BP and increase acid levels in foetus during elective cesarean.

A Randomized double blinded placebo-controlled comparative study of the fixed rate infusion regimens of phenylephrine in preventing post spinal hypotension and its effects on fetal acid base status during elective caesarean section.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048781
Enrollment
105
Registered
2023-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: PE25: 25mcg/ml infusion - 60ml per hour Intervention2: PE50: 50 mcg/ml infusion - 60ml per hour Control Intervention1: Normal Saline Infusion: 60ml per hour

Sponsors

Dr K Shanmathi Devi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA physical status II patients. 2.Patient not in labour posted for caesarean section under sub arachnoid block. 3.Singleton pregnancy. 4.Gestational age of more than 36 weeks

Exclusion criteria

Exclusion criteria: 1.Patients with hypertension (SBP >140mmHg, DBP > 90mmHg). 2.Diabetes mellitus. 3.Cardiovascular disease, cerebrovascular disease. 4.Known fetal anomalies. 5.Contra-indications to spinal Anaesthesia. 6.Signs of onset of labour. 7.BMI >45 kg/m2 8.Induction-delivery time of >10 minutes.

Design outcomes

Primary

MeasureTime frame
To assess and compare the effectiveness of different concentrations of phenylephrine infusion in preventing the maternal hypotension after the subarachnoid block for caesarean section.Timepoint: 1min,2min,3min,4min,5,min,6min,7min,8min,9min,10min,13min,16min,19min,21min,24min,27min,30min,33min,36min,39min,42min,45min—

Secondary

MeasureTime frame
To assess and compare the effectiveness of phenylephrine infusion in preventing fetal acidosis.Timepoint: 1min,2min,3min,4min,5,min,6min,7min,8min,9min,10min,13min,16min,19min,21min,24min,27min,30min,33min,36min,39min,42min,45min—

Countries

India

Contacts

Public ContactDr Shruti R Rao

BGS Global Institute of Medical Sciences

bhavyareddyha@gmail.com9880035952

Outcome results

None listed

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