Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01415284 |
Date of registration:
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10/08/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
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Scientific title:
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ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia |
Date of first enrolment:
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October 2011 |
Target sample size:
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30 |
Recruitment status: |
Recruiting |
URL:
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http://clinicaltrials.gov/show/NCT01415284 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Christian Loubert, MD, FRCPC |
Address:
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Telephone:
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Email:
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Affiliation:
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Maisonneuve-Rosemont Hospital |
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Name:
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Christian Loubert, MD, FRCPC |
Address:
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Telephone:
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514.252.3426 |
Email:
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loubertch@yahoo.fr |
Affiliation:
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Name:
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Christian Loubert, MD, FRCPC |
Address:
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Telephone:
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514.252.3426 |
Email:
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loubertch@yahoo.fr |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy pregnant women (ASA I or II)
- Normal pregnancy
- Term gestation (37 weeks and above)
- Elective cesarean section
- Spinal anesthesia
Exclusion Criteria:
- Cardiopathies
- Hypertensive disease/ pre-eclampsia / eclampsia
- Any contraindication to neuraxial anesthesia
- Patient refusal
- Body mass index > 30 at first antenatal visit and > 32 at cesarean section
- Twin pregnancy
- Known allergies to HES
- Emergency cesarean section
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obstetric Anesthesia
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Fluid Therapy
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Hypotension
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Cesarean Section
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Spinal Anesthesia
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Intervention(s)
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Drug: Hydroxyethylstarch 130/0.4
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Primary Outcome(s)
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Volume of HES which will prevent hypotension if 50 % of the subjects.
[Time Frame: 4 months]
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Secondary Outcome(s)
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cardiac output
[Time Frame: 1 hour]
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Incidence of hypotension episodes
[Time Frame: 1 hour]
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Incidence of hypertensive episodes
[Time Frame: 1 hour]
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umbilical artery pH
[Time Frame: 2 hours]
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additional vasopressors administered
[Time Frame: 1 hour]
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Apgar score
[Time Frame: 10 minutes]
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Secondary ID(s)
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LoubertHMR2011/01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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