- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06575387
The Utility of Partogram in Management
The Utility of Partogram in Management of Active Labor in Primigravidae and Its Impact In Qena Governorate
The partograph serves as "early warning system" and it has shown to be effective in preventing prolonged labour, in reducing operative interventions and in improving the neonatal outcome.
"A picture is worth a thousand words". A partograph review if well recorded provides rapid and comprehensive information about progress of labour when compared with a review of detailed handwritten case sheets. Partograph is a Latin/Greek hybrid word synonymous with parturition recorded in a graphic form.
Study Overview
Detailed Description
labour is a natural physiological process characterized by progressive increase in the frequency, intensity and duration of uterine contractions, resulting in effacement and dilatation of the cervix with descent of the foetus through the birth canal. This physiological process may take time lead to pathological one and failure to recognize this would result in prolonged labour with the resultant increase in the intensity in the morbidity and mortality of both foetus and the mother.This leads to surgical intervention with further danger to both the mother and foetus. Hence, prolonged labour and obstructed labour must be prevented by timely and effective measures, so as to give the mother a safe and happy experience of labour and child birth. The safe mother hood initiative (SMI) emphasises that the monitoring of labour for early detection of dystocia is one of the most important approaches for reducing maternal and neonatal morbidity and mortality.
In this context, the partogram has been adopted by the WHO (World health Organization) to monitor labour in maternity clinics in developing countries as a simple managerial tool to prevent prolonged labour, obstructed labour and its sequelle. The paperless partograph refers to monitoring progress of labour and reaching to an accurate decision for intervention to ensure safe delivery.
The partograph, a graphic recording of progress of labour and salient features in the mother and foetus has been used to detect labour that is not progressing normally, to help in early decision on augmentation and termination of labour.
WHO partograph is a composite graphic representation of events that takes place in labour plotted against time in hours on a pre-printed paper. It consists of three parameters:
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Asyut, Egypt
- Al-Azhar University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primigravida, 20 and 35 years old
- Gestational age 37 - 41 weeks with vertex presentation
- Singleton pregnancy
- Spontaneous or induced labour
- First stage of labour with cervical dilatation < than 7 cm.
Exclusion Criteria:
- Abnormal presentation
- Macrosomic baby
- Contacted pelvis
- Multifetal gestations
- Antepartum haemorrhage
- Cases with high risk pregnancy as Severe PIH, Severe anaemia and gestational diabetes mellitus.
- Patient refused to enrolled in the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group A: Uncomplicated Normal Labour
About 140 prime gravidae females delivered before or at alert line
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to evaluate the utility of partogram in management and progress of active labor in Primigravidae.
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Active Comparator: Group B: Complicated Normal Labour
About 40 prime gravidae females delivered between alert and action line
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to evaluate the utility of partogram in management and progress of active labor in Primigravidae.
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Active Comparator: Group C: Cesarean Section Labour
About 20 prime gravidae females delivered after action line
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to evaluate the utility of partogram in management and progress of active labor in Primigravidae.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mode of Delivery
Time Frame: 24 hours
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The mode of delivery was assessed by the condition of the mother and the fetus by BISHOP score (The Bishop score is a cervical assessment system used to predict the success of labor induction.
This scoring system evaluates several clinical parameters of the cervix, including dilation, effacement, position, consistency, and the fetal head's station in the pelvis).
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24 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Abd El-Aziz Galal El-Din El-Darwish, Professor, Al-Azhar University, Faculty of medicine, Assuit.
- Study Director: Khaled Mohamed Ahmed M. Abdallah, Assist.Professor, Al-Azhar University, Faculty of medicine, Assuit.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Manal Ahmed Mohamed
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
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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