To compare the effects of two drugs, namely mephentermine and phenylephrine, on fetus in pregnant women undergoing emergency Caesarean section under spinal anaesthesia.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/01/061722
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 ( < 1.5 ml of spinal drug)
7. Patients not needing vasopressor
support before delivery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.;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 lactate.Timepoint: After delivery of fetus.;Comparison of umbilical arterial & venous pO2 & pCO2.Timepoint: After delivery of fetus.;Comparison of Apgar scores.Timepoint: At 1 minute & 5 minutes after delivery.;Comparison of doses of mephentermine & phenylephrine used between both the groups.Timepoint: Till delivery of fetus.;Comparison of fetal birth weights.Timepoint: After delivery of fetus.