Maternal Care Bundle to Attenuate Hypotension in Cesarean Section
Primary Purpose
Hypotension, Cesarean Section Complications
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
guidance
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension
Eligibility Criteria
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
Sites / Locations
- Suez Canal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
care bundle
best-evidenced practice
Arm Description
will be subjected to a bundle of care of four elements
will be guided according to the best-evidenced performance consisting of three elements
Outcomes
Primary Outcome Measures
consumption of ephedrine
The total consumption of ephedrine used to manage the spinal induced hypotension with CS
Secondary Outcome Measures
consumption of atropine
The total consumption of atropine used to manage the spinal induced hypotension with CS
postspinal hypotension
The incidence of postspinal hypotension in CS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468125
Brief Title
Maternal Care Bundle to Attenuate Hypotension in Cesarean Section
Official Title
Special Maternal Care Bundle to Attenuate Spinal Induced Hypotension in Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Cesarean Section Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
patients will be randomly allocated by a computer software program (www. Randmizer.org) and allocation sequence will be done by opaque closed envelope.
Data will be collected by a separate anesthesiologist not sharing in the study and blinded to the technique being used.
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
care bundle
Arm Type
Active Comparator
Arm Description
will be subjected to a bundle of care of four elements
Arm Title
best-evidenced practice
Arm Type
Active Comparator
Arm Description
will be guided according to the best-evidenced performance consisting of three elements
Intervention Type
Procedure
Intervention Name(s)
guidance
Intervention Description
either follow the care bundle or the best evidence practice
Primary Outcome Measure Information:
Title
consumption of ephedrine
Description
The total consumption of ephedrine used to manage the spinal induced hypotension with CS
Time Frame
immediately at the end of the surgery
Secondary Outcome Measure Information:
Title
consumption of atropine
Description
The total consumption of atropine used to manage the spinal induced hypotension with CS
Time Frame
immediately at the end of the surgery
Title
postspinal hypotension
Description
The incidence of postspinal hypotension in CS
Time Frame
immediately at the end of the surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrhman Alshawadfy
Organizational Affiliation
Suez Canal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
ZIP/Postal Code
2685
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Maternal Care Bundle to Attenuate Hypotension in Cesarean Section
We'll reach out to this number within 24 hrs