The influence of prophylactic ephedrine on arterial hypotension and fetal dysrhythmia after combined spinal-epidural anesthesia during labour

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002456-15-BE

Enrollment

Registered

2006-05-31

Start date

2006-06-29

Completion date

Unknown

Last updated

2014-10-07

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

Conditions

Comined spinal - epiural analgesia (CSE) during labour.

Interventions

Trade Name: Ephedrine HCl Product Name: Ephedrine Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I and II singleton pregnancy spontaneous delivery gestational period > 37 weeks no indication for Caesarean 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 prematuritas arterial hypertension and pre-eclampsia allergy to local anaesthetics coagulation disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this trial is to registrate and to compare the incidence of arterial hypotension and fetal dysrythmia after CSE during labour in subjects who have an intravenous infusion with or without ephedrine.;Secondary Objective: - Registration of the neonatal outcome. - Registration of the duration of labour - Registration of adverse events (nausea, vomiting, headache, pruritus, sedation,...);Primary end point(s): Is the incidence of arterial hypotension lower in subjects who received an IV-infusion with ephedrine ?	—

Measure

Time frame

Main Objective: The main objective of this trial is to registrate and to compare the incidence of arterial hypotension and fetal dysrythmia after CSE during labour in subjects who have an intravenous infusion with or without ephedrine.;Secondary Objective: - Registration of the neonatal outcome. - Registration of the duration of labour - Registration of adverse events (nausea, vomiting, headache, pruritus, sedation,...);Primary end point(s): Is the incidence of arterial hypotension lower in subjects who received an IV-infusion with ephedrine ?

—

Countries

Belgium

Outcome results

None listed

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