Maternal Care Bundle to Attenuate Hypotension in Cesarean Section

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05468125
• Other study ID #: Maternal care bundle
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2022
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: December 1, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension

Intervention

Procedure:
• guidance
either follow the care bundle or the best evidence practice

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	consumption of atropine	The total consumption of atropine used to manage the spinal induced hypotension with CS	immediately at the end of the surgery
Secondary	postspinal hypotension	The incidence of postspinal hypotension in CS	immediately at the end of the surgery