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Electronic Partograph: A Way of Improving Partograph Use During Labour Monitoring Process in Selected District Hospitals in Bangladesh

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ClinicalTrials.gov Identifier: NCT03509103
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Background (brief):

  1. Burden: Abnormal prolonged labour and its effects are important contributors to maternal and perinatal mortality and morbidity worldwide. Although the partograph has been shown to be an efficacious tool for monitoring labor and identifying women in need of an comprehensive emergency obstetric intervention, it's appropriate use is questionable throughout the world. Evidence suggests that very few service provider use partograph despite recognizing its usefulness.
  2. Knowledge gap: In Bangladesh partograph is hardly used by the concern person though its importance and positive outcome is acknowledged at the national level. To introduce a digital partograph Johns Hopkins Program for International Education in Gynecology and Obstetrics (Jhpiego) developed an ePartogram device and WHO created partograph e-Learning tool. Jhpiego is currently testing three ePartogram implementations. However, till today, no data has been collected or analysed for any of these ePartogram models. The WHO e-Learning tool has been distributed to facilities like Kenyatta National Hospital via CD-ROM. In Kenya, a study also being conducted using a digital partograph (partopen) and results are yet to come.
  3. Relevance: The use of the paper partograph is found to be complex and too much time-consuming for effective use in low-resource settings where there has been inadequate health care staffing. These challenges highlight a need for strengthening providers' skills and/or developing new technologies that are suitable for low-resource countries and promote consistent, correct use of the partograph as well as, a labour monitoring system for the peripheral level health facilities. The benefits of this device are: ease of use, minimal training requirements, improved data quality and capture, and seamless integration into current local practice.

Objectives: The current study aims-

  1. To explore the feasibility, acceptability of digital partograph use among health service providers in selected district hospitals in Bangladesh;
  2. To compare the user rate between paper and digital partograph during labour monitoring process in district hospitals in Bangladesh;
  3. To compare the outcome of paper and digital partograph use in respect to the birth asphyxia and prolonged labour rate after introducing digital partograph in selected district hospitals in Bangladesh;
  4. To determine the barriers and facilitating factors of introducing electronic partograph in district hospital in Bangladesh.

Methods: A mixed-method prospective follow-up study with crossover design will be conducted in two DHs. One DH will serve as intervention (electronic partograph) hospital and another as control hospital (paper-based partograph). After applying the crossover design this allocation will be reversed. The total study will be completed within 18 months period. Nurse-midwives posted in obstetric wards will be the study participants. The sample size in each DH will be 506 mothers who will deliver their baby during the study period.

Outcome measures/variables:

  • Feasibility and acceptability of digital partograph use will be assessed among health service providers in selected DH in Bangladesh;
  • The user rate of digital partograph will be estimated during labour monitoring process in DHs in Bangladesh;
  • The birth asphyxia and prolonged labour rate will be estimated after introducing digital partograph in selected DHs in Bangladesh;
  • The barriers and facilitating factors of introducing electronic partograph will be determined in DHs in Bangladesh.

Condition or disease Intervention/treatment Phase
Prolonged Labor Other: Electronic Partograph Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1012 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Electronic Partograph: A Way of Improving Partograph Use During Labour Monitoring Process in Selected District Hospitals in Bangladesh
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : August 30, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electronic partograph

The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.

e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely.

Other: Electronic Partograph

The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.

e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely.


Active Comparator: Paper Partograph
An standard training on how to use and fill out partograph was conducted
Other: Electronic Partograph

The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.

e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely.





Primary Outcome Measures :
  1. User rate of Electronic Partograph [ Time Frame: 37 completed gestational weeks ]
    Increased user rate



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with spontaneous labour in the first stage of labour
  • cervical dilatation in between 4-7 centimeters
  • singleton pregnancy
  • gestation of at least 37 completed weeks
  • cephalic presentations
  • no additional complications

Exclusion Criteria:

  • women with ante partum hemorrhage
  • breech presentation,
  • multiple pregnancy,
  • premature labour (before 37 weeks)
  • Eclampsia,
  • elective caesarean section
  • induced labour
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03509103    
Other Study ID Numbers: PR-14011
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Partograpgh