Maternal Care Bundle to Attenuate Hypotension in Cesarean Section

NCT05468125 | Unknown

• 1 other identifier: Maternal care bundle
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• consumption of atropine

  immediately at the end of the surgery

• postspinal hypotension

  immediately at the end of the surgery

Study Arms (2)

care bundle

ACTIVE COMPARATOR

will be subjected to a bundle of care of four elements

Procedure: guidance

best-evidenced practice

ACTIVE COMPARATOR

will be guided according to the best-evidenced performance consisting of three elements

Procedure: guidance

Interventions

guidance PROCEDURE

either follow the care bundle or the best evidence practice

best-evidenced practice; care bundle

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 2685, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Counseling

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Abdelrhman Alshawadfy

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: August 1, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

EG (1)