Maternal Care Bundle to Attenuate Hypotension in Cesarean Section

Sponsor

Suez Canal University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05468125

Collaborator

(none)

144

Enrollment

Arms

2.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypotension Cesarean Section Complications	Procedure: guidance	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 15, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

consumption of ephedrine [immediately at the end of the surgery]
The total consumption of ephedrine used to manage the spinal induced hypotension with CS

Secondary Outcome Measures

consumption of atropine [immediately at the end of the surgery]
The total consumption of atropine used to manage the spinal induced hypotension with CS
postspinal hypotension [immediately at the end of the surgery]
The incidence of postspinal hypotension in CS

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Suez Canal University

Investigators

Principal Investigator: Abdelrhman Alshawadfy, Suez Canal University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdelrhman Alshawadfy, Lecturer of anesthesia and intensive care, Suez Canal University

ClinicalTrials.gov Identifier:

NCT05468125

Other Study ID Numbers:

Maternal care bundle

First Posted:

Jul 21, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Jul 21, 2022