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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03047109 |
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Date of registration:
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07/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ephedrine and Phenylephrine for Spinal Hypotension
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Scientific title:
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Ephedrine Versus Phenylephrine Infusion for Prevention of Spinal Hypotension During Cesarean Section: Effect on Maternal Cardiodynamics and Fetal Circulation: Randomized Double-blind Study |
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Date of first enrolment:
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February 7, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03047109 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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HAMDY A. YOUSSEF, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assiut University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age: 20-35 years.
- ASA physical I-II
- Singleton term pregnancy.
- Elective cesarean section.
Exclusion Criteria:
- Parturient refusal.
- Women with history of cardiac, respiratory, renal, neurologic or endocrine diseases.
- Women with known allergy to amide local anesthetics or any medications used in the
study.
- Any contraindications to regional anesthesia e.g. coagulopathy.
- Pre-eclampsia.
- Fetal abnormalities.
- Emergency surgeries.
- Failed or unsatisfactory spinal block.
Age minimum:
20 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Spinal Hypotension
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Intervention(s)
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Drug: Phenylephrine
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Drug: Ephedrine
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Primary Outcome(s)
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Uterine Blood Flow
[Time Frame: 30 minutes]
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Maternal Cardiac Output
[Time Frame: 30 minutes]
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Secondary Outcome(s)
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Complications
[Time Frame: 2 hours]
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APGAR score
[Time Frame: 5 minutes]
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Secondary ID(s)
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Phenylephrine Hypotension
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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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