The Effect of e-Registration and mHealth on Institutional Deliveries in the Hazard-prone Areas

May 26, 2022 updated by: Ahmed Hossain, North South University

The Effect of e-Registration and mHealth on Institutional Deliveries in the Hazard-prone Areas of Southern Bangladesh: A Protocol for an Open-label Two-arm Non-randomized Controlled Cluster Trial

The study aims to determine the effect of the eRegistration tracking system and mHealth counseling on institutional deliveries to pregnant mothers in the hazard-prone areas of Southern Bangladesh.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be an open-label two-arm non-randomized controlled cluster trial for six months period. Chandpur Sadar, Kachua, and Faridganj sub-districts will be the intervention arm and Bhola Sadar, Charfesson, and Lalmohan sub-districts of the Bhola district will be the control arm. ased system. 28 - 36 weeks of pregnant women will be enrolled, given the intervention, and followed-up until their delivery.

Study Type

Interventional

Enrollment (Anticipated)

536

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 Contact

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

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Pregnant mothers registered in the FWA register, 19 - 45 years, 28 - 36 weeks pregnant, have access to a mobile phone

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention arm will be registered in th e-Register database and recieve voice calls and text messages
Other: e-Registration and mHealth
Registration to the electronic database Counseling through voice calls for facility delivery Text messages to promote facility delivery
No Intervention: Control
The control group will be enrolled and followed until their delivery. They will not get the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Institutional delivery
Time Frame: 22 weeks

Normal vaginal deliveries, cesarean sections and assisted vaginal deliveries (forceps and vacuum deliveries) conducted at any healthcare facility by medically trained provider/ skilled birth attendant situated at the study sites will be considered as institutional delivery.

Numerator: Number of institutional deliveries Denominator: Total deliveries in the study sites (A sum of normal vaginal deliveries, cesarean sections and assisted vaginal deliveries)
22 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of different mode of deliveries
Time Frame: 22 weeks
Numerator: Proportion of normal vaginal deliveries, Proportion of cesarean sections, Proportion of forceps and vacuum deliveries Denominator: Total deliveries in the study sites.
22 weeks
Proportion of different birth outcomes
Time Frame: 22 weeks
Numerator: Proportion of alive babies, Proportion of stillbirths Denominator: Total live births in the study sites.
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North South University

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

  • Study Chair: Ahmed Hossain, Ph.D, MSc, North South University

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NorthSouthU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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