- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07926061
Clinical Audit of Labour Progress and Assisted Vaginal Birth
Clinical Audit of the Progress of Labour in Women's Health Hospital, Assiut University and Potential Use of Assisted Vaginal Delivery
This observational clinical audit aims to evaluate the recording and management of labour progress and the use of assisted vaginal birth in women admitted with the intention of vaginal delivery.
Study Overview
Status
Conditions
Detailed Description
The progress of labour is monitored using partograph or WHO Labour Care Guide standards. Assisted vaginal birth is recommended in eligible women with delay in the second stage, yet rates have declined in many settings.
This criterion-based clinical audit will review labour records of women admitted with the intention of vaginal birth and will include an anonymous staff survey to identify barriers to the use of assisted vaginal delivery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Reham A Ali, Resident
- Phone Number: +20 10 29464120
- Email: alireham120@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Women of any age and parity admitted in labour with the intention of vaginal birth at Women's Health Hospital, Assiut University.
Description
Inclusion Criteria:
- Women admitted in labour with the intention of vaginal birth
- Singleton live pregnancy with cephalic presentation
- Gestational age of 37 completed weeks or more
- Spontaneous or induced labour
Exclusion Criteria:
- - Elective caesarean section or caesarean decided before onset of labour
- Non-cephalic presentation or multiple pregnancy
- Intrauterine fetal death or major congenital anomaly
- Absolute contraindication to vaginal birth
- Delivery before arrival or transfer to another facility
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
|---|
|
Women in Labour
Women admitted in labour with the intention of vaginal birth whose records will be audited against predefined standards. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of women eligible for assisted vaginal birth
Time Frame: Baseline
|
Number of women who fulfil the predefined criteria for assisted vaginal birth during the second stage of labour. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of women who receive assisted vaginal birth
Time Frame: Baseline
|
Number of eligible women in whom assisted vaginal birth is performed. |
Baseline
|
|
Number of women delivered by caesarean section at full dilatation
Time Frame: Baseline
|
Number of eligible women delivered by caesarean section at full cervical dilatation without an attempt at assisted vaginal birth. |
Baseline
|
|
Compliance with labour progress documentation standards
Time Frame: Baseline
|
Number of cases in which labour progress is recorded according to the agreed audit standards. |
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Omar M Mohamed, prof, Obstetrics and gynecology Department, Assiut University Hospitals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Labour-Audit-Assiut-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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