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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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16 December 2017 |
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Main ID: |
NCT02961842 |
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Date of registration:
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09/11/2016 |
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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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Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
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Scientific title:
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Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery |
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Date of first enrolment:
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November 20, 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02961842 |
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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: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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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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Mohamed M Tawfik, 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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Mansoura University Hospitals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- American Society of Anesthesiologists physical status II parturients
- Full term, singleton pregnancy
- Elective cesarean delivery under spinal anesthesia
Exclusion Criteria:
- Age <19 or > 40 years
- Height <150 cm
- Weight <60 kg
- Body mass index =40 kg/m2
- Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy,
or local skin infection)
- Chronic or pregnancy-induced hypertension
- Hemoglobin <10 gm/dL.
- Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
- Polyhydramnios or known fetal abnormalities
Age minimum:
19 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anesthesia, Spinal
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Cesarean Section
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Intervention(s)
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Drug: Intravenous Ephedrine
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Drug: 500 mL Crystalloid Coload
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Procedure: Cesarean Delivery
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Drug: 1000 mL Crystalloid Coload
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Drug: Intrathecal Fentanyl
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Radiation: Ultrasound Assessment of the Inferior Vena Cava
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Procedure: Spinal Anesthesia
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Drug: 500 mL Colloid Preload
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Drug: Intrathecal Bupivacaine
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Primary Outcome(s)
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Total ephedrine dose
[Time Frame: intraoperative]
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Secondary Outcome(s)
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Inferior vena cava largest and smallest diameters
[Time Frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery]
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Heart rate
[Time Frame: intraoperative]
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Time to the first ephedrine dose
[Time Frame: intraoperative]
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Incidence of hypotension
[Time Frame: intraoperative]
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Inferior vena cava collapsibility index
[Time Frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery]
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Incidence of nausea and/or vomiting
[Time Frame: intraoperative]
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Incidence of severe hypotension
[Time Frame: intraoperative]
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Neonatal Apgar score
[Time Frame: At 1 and 5 minutes after delivery]
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Secondary ID(s)
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R/16.09.64
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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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