Maternal Care Bundle to Attenuate Hypotension in Cesarean Section

Suez Canal University

Status

Active, not recruiting

Conditions

Hypotension

Cesarean Section Complications

Treatments

Procedure: guidance

Study type

Interventional

Funder types

Other

Identifiers

NCT05468125

Maternal care bundle

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 estimated patients

Sex

Female

Ages

21 to 40 years old

Volunteers

No 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