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

A study of effect of prophylactic intravenous ephedrine on fetal and neonatal heart rate in emergency cesarean delivery due to fetal bradycardia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180411039267N3
Enrollment
96
Registered
2019-07-13
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

fetal bradycardia, prophylactic intravenous ephedrine, emergency cesarean delivery.

Interventions

Intervention 1: Intervention group: In 48 pregnant women with fetal bradycardia, as soon as mother's arrival into the operating room and after initial monitoring, one ml of intravenous ephedrine equiv

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReyhaneh Abri

Tabriz University of Medical Sciences

reyhane.abri@gmail.com+98 41 3553 9163

Outcome results

None listed

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