- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02714270
Paperless Partograph for Management of Low Risk Labor
August 1, 2018 updated by: Ahmed Mohamed Abbas, Assiut University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
370
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Assiut, Cairo, Egypt, 002
- Ahmed Abbas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria:
- Age: 18 to 40 years
- Gestational age 38-42 weeks
- Singleton pregnancy
- Vertex presentation
- Women who will accept to participate in the study
Exclusion criteria:
- Malpresentation
- Induced labour
- Multiple pregnancy
- Medical diseases with pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: modified partograph
routine modified partograph
|
|
|
Active Comparator: paperless partograph
paperless partograph with no graph paper
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of active phase of labor
Time Frame: 12 hours
|
calculated in hours between cervical dilatation more than 3 cm till fully dilated
|
12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
March 16, 2016
First Submitted That Met QC Criteria
March 18, 2016
First Posted (Estimate)
March 21, 2016
Study Record Updates
Last Update Posted (Actual)
August 2, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- WHOP-PP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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