Condition or disease | Intervention/treatment | Phase |
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Cesarean Section Complications Anesthesia Complication | Drug: Phenylephrine | Not Applicable |
Spinal anaesthesia is currently standard of care for patients undergoing caesarean section. Obstetric spinal hypotension is a common and important problem, related to important maternal and foetal outcomes. The prevention and treatment of spinal hypotension has been well researched in resource-rich settings, a context different from that encountered in the South African setting. It has been previously shown that a prophylactic phenylephrine infusion is effective in resource-limited settings, but this method is still dependent on the availability of an infusion pump.The ideal dose offering the best risk to benefit profile is 25 to 50 mcg/min. It has recently been shown that a prophylactic phenylephrine infusion, administered by an infusion pump, appears safe and effective in resource-constrained environments. However, some institutions in South Africa are limited by a lack of available infusion pumps. There is an urgent need to translate these research findings into a pragmatic management strategy that is safe and effective where this equipment is lacking. A 18g Jelco allows flow of approximately 100 ml/min in the absence of a pressure bag: therefore with 500 mcg in 1000 ml of ringers lactate and a fully opened line, a maximum dose of 50 mcg.min-1 will be achieved. If the rate is 50 ml/min (20 minutes for the first litre) the dose will be 25 mcg.min-1. This dose range will offer maximum benefit with low risk of side effects.
This exploratory study will establish if a phenylephrine (500 mcg) bolus, added to the first litre of Ringers lactate given as a co-load, is an effective and safe means to prevent post obstetric spinal hypotension. This regime will be compared to the existing South African national protocol of the management of obstetric spinal hypotension. The findings of this study will provide valuable information regarding a safe and potentially effective means to prevent obstetric spinal hypotension.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Single centre prospective alternating intervention study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prophylactic Phenylephrine and Fluid Co-administration to Reduce Spinal Hypotension During Elective Caesarean Section in a Resource-limited Setting: a Prospective Alternating Intervention Study |
Actual Study Start Date : | May 1, 2018 |
Actual Primary Completion Date : | December 31, 2018 |
Actual Study Completion Date : | December 31, 2018 |
Arm | Intervention/treatment |
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No Intervention: Bolus group
Hypotension occurring under spinal anaesthesia (SBP < 90mmHg) requires pharmacological treatment. The pharmacological management of hypotension, once diagnosed, will be the same regardless of the protocol being used. If the heart rate is greater than 70 beats per minute, phenylephrine will be administered in a dose of 50-100 mcg as an intravenous bolus. If the heart rate is less than 70 beats per minute, ephedrine will be administered in a dose of 5-10 mg. The dose within this range will be decided by the attending anaesthetist. In both arms, Ringers Lactate fluid should run fast if hypotension occurs.
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Active Comparator: Phenylephrine coload group
Phenylephrine 500ug will be added to the first litre of ringer's lactate infused on initiation of spinal anaesthesia. If the phenylephrine infusion protocol is being used, and the mean arterial pressure (MAP) rises to greater than 20% of the initial MAP, and where this rise in MAP is not due to a recent bolus of either phenylephrine or ephedrine (within 2 minutes), the Ringers Lactate infusion will be switched off. The pharmacological management of hypotension, once diagnosed, will be the same regardless of the protocol being used. If the heart rate is greater than 70 beats per minute, phenylephrine will be administered in a dose of 50-100 mcg as an intravenous bolus. If the heart rate is less than 70 beats per minute, ephedrine will be administered in a dose of 5-10 mg. In both arms, Ringers Lactate fluid should run fast if hypotension occurs.
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Drug: Phenylephrine
Prophylactic phenylephrine infusion as part of fluid coload
Other Name: Phenylephrine coload
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
South Africa | |
Edendale Hospital | |
Pietermaritzburg, KwaZulu-Natal, South Africa, 3201 |
Principal Investigator: | David G Bishop, PhD | University of KwaZulu |
Tracking Information | |||||
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First Submitted Date ICMJE | June 19, 2019 | ||||
First Posted Date ICMJE | July 2, 2019 | ||||
Last Update Posted Date | July 2, 2019 | ||||
Actual Study Start Date ICMJE | May 1, 2018 | ||||
Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Post spinal hypotension [ Time Frame: from insertion of spinal anaesthesia until the delivery of the baby ] The incidence of post spinal hypotension (SBP <90 mmHg)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Prophylactic Phenylephrine Co-administration During Caesarean Section | ||||
Official Title ICMJE | Prophylactic Phenylephrine and Fluid Co-administration to Reduce Spinal Hypotension During Elective Caesarean Section in a Resource-limited Setting: a Prospective Alternating Intervention Study | ||||
Brief Summary | This single centre prospective alternating intervention study will aim to compare prophylactic phenylephrine given in the first litre of Ringers lactate as co-load in healthy patients having an elective caesarean section under spinal anaesthesia at Edendale Hospital to the existing national protocol guideline - for the treatment of obstetric spinal hypotension. | ||||
Detailed Description |
Spinal anaesthesia is currently standard of care for patients undergoing caesarean section. Obstetric spinal hypotension is a common and important problem, related to important maternal and foetal outcomes. The prevention and treatment of spinal hypotension has been well researched in resource-rich settings, a context different from that encountered in the South African setting. It has been previously shown that a prophylactic phenylephrine infusion is effective in resource-limited settings, but this method is still dependent on the availability of an infusion pump.The ideal dose offering the best risk to benefit profile is 25 to 50 mcg/min. It has recently been shown that a prophylactic phenylephrine infusion, administered by an infusion pump, appears safe and effective in resource-constrained environments. However, some institutions in South Africa are limited by a lack of available infusion pumps. There is an urgent need to translate these research findings into a pragmatic management strategy that is safe and effective where this equipment is lacking. A 18g Jelco allows flow of approximately 100 ml/min in the absence of a pressure bag: therefore with 500 mcg in 1000 ml of ringers lactate and a fully opened line, a maximum dose of 50 mcg.min-1 will be achieved. If the rate is 50 ml/min (20 minutes for the first litre) the dose will be 25 mcg.min-1. This dose range will offer maximum benefit with low risk of side effects. This exploratory study will establish if a phenylephrine (500 mcg) bolus, added to the first litre of Ringers lactate given as a co-load, is an effective and safe means to prevent post obstetric spinal hypotension. This regime will be compared to the existing South African national protocol of the management of obstetric spinal hypotension. The findings of this study will provide valuable information regarding a safe and potentially effective means to prevent obstetric spinal hypotension. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Single centre prospective alternating intervention study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Phenylephrine
Prophylactic phenylephrine infusion as part of fluid coload
Other Name: Phenylephrine coload
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
300 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | December 31, 2018 | ||||
Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | South Africa | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04005664 | ||||
Other Study ID Numbers ICMJE | BE616/17 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of KwaZulu | ||||
Study Sponsor ICMJE | University of KwaZulu | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of KwaZulu | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |