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Prophylactic Phenylephrine Co-administration During Caesarean Section

Prophylactic Phenylephrine and Fluid Co-administration to Reduce Spinal Hypotension During Elective Caesarean Section in a Resource-limited Setting: a Prospective Alternating Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04005664
Enrollment
300
Registered
2019-07-02
Start date
2018-05-01
Completion date
2018-12-31
Last updated
2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Complication, Cesarean Section Complications

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.

Interventions

DRUGPhenylephrine

Prophylactic phenylephrine infusion as part of fluid coload

Sponsors

University of KwaZulu
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single centre prospective alternating intervention study

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* All ASA 1-2 patients undergoing elective caesarean

Exclusion criteria

* ASA grade \>2 Hypertensive disease in pregnancy Dysrhythmia Failed spinal requiring conversion to a general anaesthetic

Design outcomes

Primary

MeasureTime frameDescription
Post spinal hypotensionfrom insertion of spinal anaesthesia until the delivery of the babyThe incidence of post spinal hypotension (SBP \<90 mmHg)

Secondary

MeasureTime frameDescription
Maternal cardiac arresttime of spinal insertion till delivery of the babyRequirement for cardiopulmonary resuscitation
Maternal bradycardiatime of spinal insertion till delivery of the babymaternal bradycardia requiring atropine administration
Requirement for vasopressortime of spinal insertion till delivery of the babyNumber of vasopressor boluses
Maternal symptomstime of spinal insertion till delivery of the babynausea, vomiting, headache and dizziness.
Lowest blood pressuretime of spinal insertion till delivery of the babyLowest systolic blood pressure (mmHg)
Lowest maternal heart ratetime of spinal insertion till delivery of the babyLowest heart rate (beats per minute)
Highest blood pressuretime of spinal insertion till delivery of the babyHighest systolic blood pressure (mmHg)

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026