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Paperless Partograph for Management of Low Risk Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714270
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE March 21, 2016
Last Update Posted Date August 2, 2018
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
Duration of active phase of labor [ Time Frame: 12 hours ]
calculated in hours between cervical dilatation more than 3 cm till fully dilated
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
Number of successful vaginal deliveries [ Time Frame: intraoperative ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paperless Partograph for Management of Low Risk Labor
Official Title  ICMJE A Randomized Clinical Trial of Paperless Versus Modified World Health Organization Partograph in Management of First Stage of Labour
Brief 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 outcomes

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Normal Labor
Intervention  ICMJE
  • Procedure: modified partograph
  • Procedure: paperless partograph
Study Arms  ICMJE
  • Active Comparator: modified partograph
    routine modified partograph
    Intervention: Procedure: modified partograph
  • Active Comparator: paperless partograph
    paperless partograph with no graph paper
    Intervention: Procedure: paperless partograph
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2016)
370
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Age: 18 to 40 years
  2. Gestational age 38-42 weeks
  3. Singleton pregnancy
  4. Vertex presentation
  5. Women who will accept to participate in the study

Exclusion criteria:

  1. Malpresentation
  2. Induced labour
  3. Multiple pregnancy
  4. Medical diseases with pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714270
Other Study ID Numbers  ICMJE WHOP-PP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ahmed Mohamed Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP