Normal LaborNCT02714270
Paperless Partograph for Management of Low Risk Labor
A study testing modified partograph and paperless partograph in people with Normal Labor, run by Assiut University at 1 site in Egypt.
Trial summary
Paperless partograph is a technique used for monitoring the progress of labor before delivery, and arriving at the accurate time to intervene for ensuring a safe delivery. The study will be carried out to find out the effectiveness of paperless partograph in management of labor and its effect on maternal and neonatal… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Normal Labor
- What is being tested?
- modified partograph and paperless partograph
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Jun 2018
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 40 years
- Gestational age 38-42 weeks
- Singleton pregnancy
- Vertex presentation
- Women who will accept to participate in the study
Who cannot join
- Malpresentation
- Induced labour
- Multiple pregnancy
- Medical diseases with pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Paperless Versus Modified World Health Organization Partograph in Management of First Stage of Labour
Paperless partograph is a technique used for monitoring the progress of labor before delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.
The study will be carried out to find out the effectiveness of paperless partograph in management of labor and its effect on maternal and neonatal outcomes
- Conditions
- Normal Labor
- Being tested
- modified partograph, paperless partograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified partographProcedure or surgery
paperless partographProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| modified partograph | Active comparator | routine modified partograph Receives: Procedure: modified partograph |
| paperless partograph | Active comparator | paperless partograph with no graph paper Receives: Procedure: paperless partograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of active phase of labor
calculated in hours between cervical dilatation more than 3 cm till fully dilated
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal LaborStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714270
- Sponsor's protocol ID
- WHOP-PP
- Status last verified
- Aug 2018
- First submitted
- 16 Mar 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Paperless Versus Modified World Health Organization Partograph in Management of First Stage of Labour
- ClinicalTrials.gov ID
- NCT02714270
- Acronym / sponsor ID
- WHOP-PP
- Conditions
- Normal Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 21 Mar 2016 (estimated)
- 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.
Paperless partograph is a technique used for monitoring the progress of labor before delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.
The study will be carried out to find out the effectiveness of paperless partograph in management of labor and its effect on maternal and neonatal outcomes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified partograph | Active comparator | Procedure: modified partographroutine modified partograph |
| paperless partograph | Active comparator | Procedure: paperless partographpaperless partograph with no graph paper |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 to 40 years
- Gestational age 38-42 weeks
- Singleton pregnancy
- Vertex presentation
- Women who will accept to participate in the study
Key exclusion criteria (4 listed)
- Malpresentation
- Induced labour
- Multiple pregnancy
- Medical diseases with pregnancy
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 |
|---|---|---|
| modified partograph | Procedure or surgery | modified partograph |
| paperless partograph | Procedure or surgery | paperless partograph |
Primary outcome
Duration of active phase of labor
Time frame: 12 hours
calculated in hours between cervical dilatation more than 3 cm till fully dilated
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 2 Aug 2018.
- Individual participant dataSharing planned: Yes
Related trials for Normal Labor
Not yet recruitingObservational study
Comparison Between Using 10min CTG in Fetal Monitoring Instead of 30min Monitoring in Low Resources Overcrowded Hospitals.
Normal Pregnancy, Labor Active Dilated Cm
RecruitingPhase 4
Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
Vaginal Delivery, Normal Labor
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified partograph and paperless partograph in people with Normal Labor, run by Assiut University 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 4 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 2 Aug 2018. 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?
Duration of active phase of labor (time frame: 12 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 2 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.