NCT05398978

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
536

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 23, 2022

Last Update Submit

May 26, 2022

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Proportion of different mode of deliveries

    22 weeks

  • Proportion of different birth outcomes

    22 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will be registered in th e-Register database and recieve voice calls and text messages

Other: e-Registration and mHealth

Control

NO INTERVENTION

The control group will be enrolled and followed until their delivery. They will not get the intervention.

Interventions

Registration to the electronic database Counseling through voice calls for facility delivery Text messages to promote facility delivery

Intervention

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWe will include pregnant mothers for our study. Participant eligibility is based on thier pregnancy status and self-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Pregnant mothers registered in the FWA register, 19 - 45 years, 28 - 36 weeks pregnant, have access to a mobile phone

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Chowdhury AT, Jabeen S, Sultana ZZ, Rahman AE, Arifeen SE, Hossain A. Evaluating the impact of e-registration and mHealth on institutional delivery in hazard-prone areas of Bangladesh: A protocol for a non-randomized controlled cluster trial. PLoS One. 2023 Sep 27;18(9):e0271364. doi: 10.1371/journal.pone.0271364. eCollection 2023.

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ahmed Hossain, Ph.D, MSc

    North South University

    STUDY CHAIR

Central Study Contacts

Ahmed Hossain, Ph.D, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 1, 2022

Study Start

June 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

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