Maternal Care Bundle to Attenuate Hypotension in Cesarean Section

Study Overview
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Brief Summary
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Cesarean Section (CS) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. Hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal nausea and vomiting, fetal acidosis and may be an important contributory factor for maternal death related to regional anaesthesia.

Detailed Description
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A variety of methods have been used for the prevention of post-spinal hypotension which includes the use of intravenous fluid, vasopressors, and physical methods such as table tilt, leg binders, and compression devices. However, a single technique is ineffective and a combination of interventions is suggested. A care bundle is a group of three to five evidence-based interventions that, when performed together, have a better outcome than if performed individually. A care bundle consists of a group of (usually) between three and five evidence-based interventions. These are related to a particular condition or event for patient care. Care bundles are well known in the field of intensive care medicine such as Ventilator-Associated Pneumonia (VAP) care bundle, sepsis care bundle, and Central Line-Associated Bloodstream Infection (CLABSI) care bundle. To our knowledge, till now, no one has investigated a special care bundle in the field of anaesthesia. In this work, we will investigate the safety and efficacy of a special care bundle in controlling spinal induced hypotension.

Official Title
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Special Maternal Care Bundle to Attenuate Spinal Induced Hypotension in Cesarean Section

Conditions
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Hypotension, Cesarean Section Complications

Intervention / Treatment
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* Procedure: guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 21 years old and less than 40 years. Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations). None laboring, at term with singleton uncomplicated pregnancies. Delivery under spinal anesthesia, with height 150 to 180 cm Body mass index of at most 40 kg/m2. Exclusion Criteria: Parturient with peri-partum disorders as DM, HTN, cardiac diseases, bronchial asthma or bleeding disorders Obesity: BMI >40 Any known allergy to local anesthetic drugs or ondansetron. Apparent anatomical abnormalities or infections in the back region. Bleeding disorders e.g., thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney). Refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: care bundle<br>will be subjected to a bundle of care of four elements | Procedure: guidance<br>* either follow the care bundle or the best evidence practice<br>|
| Active Comparator: best-evidenced practice<br>will be guided according to the best-evidenced performance consisting of three elements | Procedure: guidance<br>* either follow the care bundle or the best evidence practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of ephedrine | The total consumption of ephedrine used to manage the spinal induced hypotension with CS | immediately at the end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of atropine | The total consumption of atropine used to manage the spinal induced hypotension with CS | immediately at the end of the surgery | 
| postspinal hypotension | The incidence of postspinal hypotension in CS | immediately at the end of the surgery |