NCT03509103

Brief Summary

Background (brief):

  • 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

April 16, 2018

Last Update Submit

May 4, 2018

Conditions

Keywords

Partograpgh

Outcome Measures

Primary Outcomes (1)

  • User rate of Electronic Partograph

    Increased user rate

    37 completed gestational weeks

Study Arms (2)

Electronic partograph

EXPERIMENTAL

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

Paper Partograph

ACTIVE COMPARATOR

An standard training on how to use and fill out partograph was conducted

Other: Electronic Partograph

Interventions

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.

Electronic partographPaper Partograph

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • women with ante partum hemorrhage
  • breech presentation,
  • multiple pregnancy,
  • premature labour (before 37 weeks)
  • Eclampsia,
  • elective caesarean section
  • induced labour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rahman A, Begum T, Ashraf F, Akhter S, Hoque DME, Ghosh TK, Rahman M, Stekelenburg J, Das SK, Fatima P, Anwar I. Feasibility and effectiveness of electronic vs. paper partograph on improving birth outcomes: A prospective crossover study design. PLoS One. 2019 Oct 7;14(10):e0222314. doi: 10.1371/journal.pone.0222314. eCollection 2019.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 26, 2018

Study Start

February 1, 2015

Primary Completion

August 30, 2016

Study Completion

December 31, 2016

Last Updated

May 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share