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Plasma Volume Expander

ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia

Phase 4
Waitlist Available
Led By Christian Loubert, MD, FRCPC
Research Sponsored by Maisonneuve-Rosemont Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.

Eligible Conditions
  • Cesarean Section
  • Low Blood Pressure
  • Fluid Therapy
  • Obstetric Anesthesia
  • Spinal Anesthesia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hydroxyethylstarch 130/0.4Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Maisonneuve-Rosemont HospitalLead Sponsor
101 Previous Clinical Trials
38,297 Total Patients Enrolled
Université de MontréalOTHER
221 Previous Clinical Trials
104,262 Total Patients Enrolled
Christian Loubert, MD, FRCPCPrincipal InvestigatorMaisonneuve-Rosemont Hospital
2 Previous Clinical Trials
60 Total Patients Enrolled
~2 spots leftby Dec 2025
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