To compare the effects of two drugs, namely mephentermine and phenylephrine, on fetus in pregnant women undergoing emergency Caesarean section under spinal anaesthesia.

Comparison of effects of mephentermine versus phenylephrine on foetal acid-base status in pregnant women undergoing Caesarean section under spinal anaesthesia with acute foetal compromise: A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061722

Enrollment

166

Registered

2024-01-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Mephentermine: One set of study participants will receive Inj. Mephentermine as the vasopressor of choice for management of post spinal hypotension in bolus doses of 3 mg, given intrave

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women planned for emergency Caesarean section under spinal anesthesia with pathological CTG abnormalities. 2. Singleton pregnancy 3. More than 36 weeks of gestation

Exclusion criteria

Exclusion criteria: 1. Pregnant women with cardiovascular disease of NYHA Class III and IV. 2. Preeclampsia with severe features 3. Pregnant women with respiratory disease of MMRC Grade III and IV 4. Pregnant women with restrictive fluid strategies like acute and chronic kidney failure, acute pulmonary oedema 5. Pregnant women with weight more than 100 kg 6. Pregnant women planned for low dose spinal ( 7. Patients not needing vasopressor support before delivery.

Design outcomes

Primary

Measure	Time frame
To determine the effects of mephentermine and phenylephrine on umbilical arterial PH in pregnant women undergoing Caesarean section for acute foetal compromise.Timepoint: Within 5 minutes of neonate delivery (only one time collection of cord blood sample)	—

Secondary

Measure	Time frame
Comparison of umbilical arterial & venous base excess or deficit.Timepoint: After delivery of fetus.;Comparison of umbilical arterial & venous bicarbonate.Timepoint: After delivery of fetus.;Comparison of umbilical arterial & venous pO2 & pCO2.Timepoint: After delivery of fetus.;Comparison of umbilical arterial & venous lactate.Timepoint: After delivery of fetus.;Comparison of Apgar scores.Timepoint: At 1 minute & 5 minutes after delivery.;Comparison of fetal birth weights.Timepoint: After delivery of fetus.;Comparison of doses of mephentermine & phenylephrine used between both the groups.Timepoint: Till delivery of fetus.;Comparison of maternal hemodynamics, heart rate & blood pressure between the two groups.Timepoint: At 1-minute intervals till delivery of fetus.;Comparison of maternal hypotensive episodes, hypertensive episodes, & bradycardia between both groups.Timepoint: At 1-minute intervals till delivery of fetus.;Comparison of maternal IONV between both groupsTimepoint: Till end of surgery.	—

Measure

Time frame

Comparison of umbilical arterial & venous base excess or deficit.Timepoint: After delivery of fetus.;Comparison of umbilical arterial & venous bicarbonate.Timepoint: After delivery of fetus.;Comparison of umbilical arterial & venous pO2 & pCO2.Timepoint: After delivery of fetus.;Comparison of umbilical arterial & venous lactate.Timepoint: After delivery of fetus.;Comparison of Apgar scores.Timepoint: At 1 minute & 5 minutes after delivery.;Comparison of fetal birth weights.Timepoint: After delivery of fetus.;Comparison of doses of mephentermine & phenylephrine used between both the groups.Timepoint: Till delivery of fetus.;Comparison of maternal hemodynamics, heart rate & blood pressure between the two groups.Timepoint: At 1-minute intervals till delivery of fetus.;Comparison of maternal hypotensive episodes, hypertensive episodes, & bradycardia between both groups.Timepoint: At 1-minute intervals till delivery of fetus.;Comparison of maternal IONV between both groupsTimepoint: Till end of surgery.

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Countries

India

Contacts

Public ContactVijay Krishnan

Jawaharlal Institute of Postgraduate Medical Education

vijaykrishnanu96@gmail.com8524879931

Outcome results

None listed

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