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

Sponsor

North South University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05398978

Collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh (Other)

536

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Place of Delivery	Other: e-Registration and mHealth	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

536 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The pregnant mothers will be registered in the electronic database, they will be called by the midwives to motivate them for facility delivery and they will receive a text message regarding this.The pregnant mothers will be registered in the electronic database, they will be called by the midwives to motivate them for facility delivery and they will receive a text message regarding this.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of Institutional delivery [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)

Secondary Outcome Measures

Proportion of different mode of deliveries [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.
Proportion of different birth outcomes [22 weeks]
Numerator: Proportion of alive babies, Proportion of stillbirths Denominator: Total live births in the study sites.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

North South University
International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Hossain, Professor, North South University

ClinicalTrials.gov Identifier:

NCT05398978

Other Study ID Numbers:

NorthSouthU

First Posted:

Jun 1, 2022

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Hossain, Professor, North South University

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

Study Results

No Results Posted as of Jun 1, 2022