Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension

August 26, 2022 updated by: Mitiku Desalegn, Wachemo University

Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension During Elective Caesarean Section in Resource Limited Setting: a Prospective Cohort Study

This study was conducted to compare the effectiveness of ephedrine versus norepinephrine for management of hypotension after spinal anesthesia for mothers undergoing elective cesarean section

Study Overview

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hosa'ina, Ethiopia
        • Wachemo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All pregnant women undergoing elective cesarean section fulfills the inclusion criteria were the source population

Description

Inclusion Criteria:

  • ASA class II and ages ranging from 18-35 years were included in the study

Exclusion Criteria:

  • pregnant women with preeclampsia/eclampsia, baseline hypertension (SBP> 140 mm Hg), BMI> 30 kg/m2, failed spinal, spinal anaesthesia converted to general anaesthesia, contraindication for spinal anaesthesia and mother with cardiovascular, renal or hepatic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to compare mean blood pressure (MAP) between the groups
Time Frame: From March,01 to April, 30/2022
From March,01 to April, 30/2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE2323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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