Effect of ephedrine on fetal and neonatal heart rate in emergency cesarean delivery due to fetal bradycardia

Phase 3

• Conditions: fetal bradycardia, prophylactic intravenous ephedrine, emergency cesarean delivery.

• Registration Number: IRCT20180411039267N3
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

Term pregnancy
Physical status of American society of Anesthesiology (ASA) class I or II
fetal bradycardia
candidate for emergency cesarean with spinal anesthesia
Informed consent
18 to 45 years old

Exclusion Criteria

Contraindication of regional anesthesia
Gestational hypertension, preeclampsia, eclampsia
HELLP syndrome (Hemolysis, increased liver enzyms, low platelet)
Maternal co-existing disease such as heart disease which ephedrine administration is contraindicated
Emergency Cesarean section due to peripartum hemorrhage, umbilical cord prolapse

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal and neonatal heart rate. Timepoint: Measuring fetal heart rate at the entrance to the operating room, one minute after ephedrine or placebo injection, immediately after the spinal anesthesia, measuring the neonatal heart rate immediately, 5 and 10 minutes after birth. Method of measurement: The fetal heart rate is measured by sonochade and neonatal heart rate by pulse oximeter and will be recorded in the checklist prepared for this purpose.

Secondary Outcome Measures

Name	Time	Method
APGAR score in the 1, 5, 10th minutes of birth. Timepoint: in the 1, 5, 10th minutes after birth. Method of measurement: Observe and examination of the baby in minutes 1, 5 and 10.;Admission rate of the neonate in NICU. Timepoint: While baby's transfer to the neonatal ward or NICU. Method of measurement: Record from the patient file.;Neonatal arterial blood gases. Timepoint: Immediately after clamp of umbilical cord. Method of measurement: neonatal arterial blood gases analysis.;Maternal blood pressure and the need for additional ephedrine. Timepoint: Every 2 minutes up to 10 minutes, then every 5 minutes up to 30 minutes, and then every 10 minutes until the end of operation. Method of measurement: Measurement by non-invasive barometer cuff of vital signs monitoring device.