Vaginal DeliveryNCT05143944
Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project
An observational study of Vaginal Delivery, run by Assiut University.
Trial summary
auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Delivery
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: normal vaginal dellivary of primigravida
Who may be able to join
- term 37- 41 weeks primigravida single vertex presentation living fetus spontaneous onset no contraindications for vaginal delivary
Who cannot join
- women with associated co morbidities pre eclampsia and diabetes IUFD previous uterine scar intrauterine growth restriction
About this study
auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care
Read the 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
- Conditions
- Vaginal Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
measure performance according to gold standers
measure performance and adherence to gold standers during management of first stage of labour in assuit university hospitals
Measured: BASELINE
Secondary outcomes (1)
introduction of NICE guidelines in practice
introduction of NICE guidelines in management of first stage of labour in practice in assuit university hospitals
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Maksy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143944
- Sponsor's protocol ID
- audit of first stage of labour
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project
- ClinicalTrials.gov ID
- NCT05143944
- Acronym / sponsor ID
- audit of first stage of labour
- Conditions
- Vaginal Delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- normal vaginal dellivary of primigravida
Key inclusion criteria (1 listed)
- term 37- 41 weeks primigravida single vertex presentation living fetus spontaneous onset no contraindications for vaginal delivary
Key exclusion criteria (1 listed)
- women with associated co morbidities pre eclampsia and diabetes IUFD previous uterine scar intrauterine growth restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
introduction of NICE guidelines in practice
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Delivery, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure performance according to gold standers (time frame: BASELINE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.