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

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: Place of Delivery
• Intervention / Treatment: Other: e-Registration and mHealth

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

• Study Contact: Name: Ahmed Hossain, Ph.D, MSc; Phone Number: +8801729378236; Email: ahmed.hossain@northsouth.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	Numerator: Proportion of alive babies, Proportion of stillbirths Denominator: Total live births in the study sites.	22 weeks

Collaborators and Investigators

• 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

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: Non-randomized controlled cluster trial; institutional delivery; e-Registration; mHealth
• 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