- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05143944
Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project
November 23, 2021 updated by: Mohamed Mahmoud Maksy, Assiut University
auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Clinical auditing is a quality improvement process that involves reviewing the delivery of healthcare to ensure the best practice is being carried out . it is agreed that caesarean section rates are above the nationally accepted in Egypt .
This can be related to many factors and can be associated with risks to morbidities and mortalities
Study Type
Observational
Enrollment (Anticipated)
400
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
normal vaginal dellivary of primigravida
Description
Inclusion Criteria:
- term 37- 41 weeks primigravida single vertex presentation living fetus spontaneous onset no contraindications for vaginal delivary
Exclusion Criteria:
- women with associated co morbidities pre eclampsia and diabetes IUFD previous uterine scar intrauterine growth restriction
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
Cohorts and Interventions
Group / Cohort |
---|
Nice clinical guidelines for intrapartum care for healthy women and babies
define gold standards in intrapartum care for healthy women and babies
|
performance in the care provided to patients in periods of audit
measure performance in the care provided to the patients in the period of audit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure performance according to gold standers
Time Frame: BASELINE
|
measure performance and adherence to gold standers during management of first stage of labour in assuit university hospitals
|
BASELINE
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
introduction of NICE guidelines in practice
Time Frame: baseline
|
introduction of NICE guidelines in management of first stage of labour in practice in assuit university hospitals
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
December 1, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
November 23, 2021
First Submitted That Met QC Criteria
November 23, 2021
First Posted (Actual)
December 3, 2021
Study Record Updates
Last Update Posted (Actual)
December 3, 2021
Last Update Submitted That Met QC Criteria
November 23, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- audit of first stage of labour
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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