NCT05522088

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 25, 2022

Last Update Submit

August 26, 2022

Conditions

Comparing Ephedrine With Norepinephrine for Mangement Postspinal Hypotension

Outcome Measures

Primary Outcomes (1)

  • to compare mean blood pressure (MAP) between the groups

    From March,01 to April, 30/2022

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wachemo University

Hosa’ina, Ethiopia

Location

Related Publications (1)

  • Desalegn M, Shitemaw T, Tamrat H. Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Postspinal Hypotension during Elective Caesarean Section in Resource Limited Setting: A Prospective Cohort Study. Anesthesiol Res Pract. 2022 Oct 3;2022:7170301. doi: 10.1155/2022/7170301. eCollection 2022.

    PMID: 36225250DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 30, 2022

Study Start

March 1, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ET(1)