Place of DeliveryNCT05398978
The Effect of e-Registration and mHealth on Institutional Deliveries in the Hazard-prone Areas
A study testing e-Registration and mHealth in people with Place of Delivery, run by North South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Place of Delivery
- What is being tested?
- e-Registration and mHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Pregnant mothers registered in the FWA register, 19 - 45 years, 28 - 36 weeks pregnant, have access to a mobile phone
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Place of Delivery
- Being tested
- e-Registration and mHealth
- Keywords
- Non-randomized controlled cluster trial; institutional delivery; e-Registration; mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Registration and mHealthOther
Registration to the electronic database Counseling through voice calls for facility delivery Text messages to promote facility delivery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will be registered in th e-Register database and recieve voice calls and text messages Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 22 weeks
Secondary outcomes (2)
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.
Measured: 22 weeks
Proportion of different birth outcomes
Numerator: Proportion of alive babies, Proportion of stillbirths Denominator: Total live births in the study sites.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Place of DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North South University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Ahmed Hossain, North South University
- Investigators
- Ahmed Hossain, Ph.D, MSc, Study chair, North South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398978
- Sponsor's protocol ID
- NorthSouthU
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual participant data available to other researchers.
Publications
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.
PubMed 37756321
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05398978
- Acronym / sponsor ID
- NorthSouthU
- Conditions
- Place of Delivery
- Keywords
- Non-randomized controlled cluster trial; institutional delivery; e-Registration; mHealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- North South UniversityUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: e-Registration and mHealthThe intervention arm will be registered in th e-Register database and recieve voice calls and text messages |
| Control | No intervention | –The control group will be enrolled and followed until their delivery. They will not get the intervention. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-Registration and mHealthRegistration to the electronic database Counseling through voice calls for facility delivery Text messages to promote facility delivery | Other | Intervention |
Primary outcome
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)
2 secondary outcomes
Proportion of different mode of deliveries
Time frame: 22 weeks
Proportion of different birth outcomes
Time frame: 22 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 37756321Chowdhury 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.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Hossain, Ph.D, MSc study chair
North South University
Questions about this trial
What is this clinical trial studying?
A study testing e-Registration and mHealth in people with Place of Delivery, run by North South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hossain, Ph.D, MSc (+8801729378236, ahmed.hossain@northsouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Institutional delivery (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.