NCT05143944

Brief Summary

auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

November 23, 2021

Last Update Submit

November 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • measure performance according to gold standers

    measure performance and adherence to gold standers during management of first stage of labour in assuit university hospitals

    BASELINE

Secondary Outcomes (1)

  • introduction of NICE guidelines in practice

    baseline

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall women in reproductive age
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

normal vaginal dellivary of primigravida

You may qualify if:

  • term 37- 41 weeks primigravida single vertex presentation living fetus spontaneous onset no contraindications for vaginal delivary

You may not qualify if:

  • women with associated co morbidities pre eclampsia and diabetes IUFD previous uterine scar intrauterine growth restriction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
audit of management of first stage of labour in Assiut university hospitals : a quality improvement project

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 3, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

December 3, 2021

Record last verified: 2021-11