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Vasopressors for Hypotension During Cesarean Section in Severe Preeclampsia
NCT01451060Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jun 2011
- Primary completion
- Jun 2014
- Countries
- 1
- Sponsor
- IMIP
- Modality
- Orthosteric Ligands
- Drugs
- metahydroxylamine
- Conditions
- hypotension
01
Overview
Phase 3, randomised, double-blind trial of metahydroxylamine in hypotension (2 arms), sponsored by IMIP. Primary endpoint: Incidence of maternal hypotension at 30 months. Planned start Jun 2011; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Metaraminol
0.5 mg administered for any fall in blood pressure until birth.
Ephedrine
1 mg administered for any fall in blood pressure until birth.
03
Who it enrols
Pregnant women with severe preeclampsia, gestational age >34 weeks, single pregnancy, requiring cesarean section under spinal anesthesia.
04
Endpoints
Primary
Incidence of maternal hypotension
Secondary
Maternal and Neonatal outcomes
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