Labor OnsetNCT06575387
The Utility of Partogram in Management
A study testing Partogram in people with Labor Onset, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Labor Onset
- What is being tested?
- Partogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 10 Sep 2024
- Phase
- Interventional
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Conditions
- Labor Onset
- Being tested
- Partogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PartogramProcedure or surgery
to evaluate the utility of partogram in management and progress of active labor in Primigravidae.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Uncomplicated Normal Labour | Active comparator | About 140 prime gravidae females delivered before or at alert line Receives: Procedure: Partogram |
| Group B: Complicated Normal Labour | Active comparator | About 40 prime gravidae females delivered between alert and action line Receives: Procedure: Partogram |
| Group C: Cesarean Section Labour | Active comparator | About 20 prime gravidae females delivered after action line Receives: Procedure: Partogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of Delivery
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor OnsetStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- Abd El-Aziz Galal El-Din El-Darwish, Professor, Study chair, Al-Azhar University, Faculty of medicine, Assuit.Khaled Mohamed Ahmed M. Abdallah, Assist.Professor, Study director, Al-Azhar University, Faculty of medicine, Assuit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575387
- Sponsor's protocol ID
- Manal Ahmed Mohamed
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Partogram in Management of Active Labor in Primigravidae and Its Impact In Qena Governorate
- ClinicalTrials.gov ID
- NCT06575387
- Acronym / sponsor ID
- Manal Ahmed Mohamed
- Conditions
- Labor Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 28 Aug 2024 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Uncomplicated Normal Labour | Active comparator | Procedure: PartogramAbout 140 prime gravidae females delivered before or at alert line |
| Group B: Complicated Normal Labour | Active comparator | Procedure: PartogramAbout 40 prime gravidae females delivered between alert and action line |
| Group C: Cesarean Section Labour | Active comparator | Procedure: PartogramAbout 20 prime gravidae females delivered after action line |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Abnormal presentation
- Macrosomic baby
- Contacted pelvis
- Multifetal gestations
- Antepartum haemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partogramto evaluate the utility of partogram in management and progress of active labor in Primigravidae. | Procedure or surgery | Group A: Uncomplicated Normal Labour, Group B: Complicated Normal Labour, Group C: Cesarean Section Labour |
Primary outcome
Mode of Delivery
Time frame: 24 hours
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Abd El-Aziz Galal El-Din El-Darwish, Professor study chair
Al-Azhar University, Faculty of medicine, Assuit.
Khaled Mohamed Ahmed M. Abdallah, Assist.Professor study director
Al-Azhar University, Faculty of medicine, Assuit.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partogram in people with Labor Onset, run by Egymedicalpedia at 1 site in Egypt.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mode of Delivery (time frame: 24 hours). 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 29 Aug 2025.