Maternal Care Bundle to Attenuate Hypotension in Cesarean Section

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cesarean Section Complications; Hypotension
• Intervention / Treatment: Procedure: guidance

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 2685
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: Abdelrhman Alshawadfy, Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): November 20, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: Maternal care bundle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No