Low dose of ephedrine versus phenylephrine in the prevention of arterial hypotension after low dosed CSE for elective C-section : is there a difference in umbilical blood gas values ?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003926-11-BE

Enrollment

Registered

2007-08-22

Start date

2007-10-03

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

combined spinal-epidural analgesia during C-section

Interventions

Trade Name: Ephedrine-sterop 50 mg/ml Pharmaceutical Form: Injection* CAS Number: 50-98-6 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - ASA I and II - singleton pregnancy - > 36 weeks gestational stage - elective C-section Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - ASA III and IV - (pre)eclampsia - intake of anti-hypertensive medication - contra-indication for loco-regional anesthesia

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if there is a significant difference between the umbilical blood gas levelsbetweeen subjects who received ephedrine as phrophylactic treatment for postspinal hypotension and subjects whe received phenylephrin.;Secondary Objective: - incidence of arterial hypotension - incidence of bradycardia and tachycardia;Primary end point(s): Has the administrion of a low, prophylactic dose of ephedrine an influence on the umbilical arterial pH ?	—

Measure

Time frame

Main Objective: To evaluate if there is a significant difference between the umbilical blood gas levelsbetweeen subjects who received ephedrine as phrophylactic treatment for postspinal hypotension and subjects whe received phenylephrin.;Secondary Objective: - incidence of arterial hypotension - incidence of bradycardia and tachycardia;Primary end point(s): Has the administrion of a low, prophylactic dose of ephedrine an influence on the umbilical arterial pH ?

—

Countries

Belgium

Outcome results

None listed

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