Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623000057684
Ethics application status
Approved
Date submitted
9/01/2023
Date registered
17/01/2023
Date last updated
19/10/2023
Date data sharing statement initially provided
17/01/2023
Date results information initially provided
19/10/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Interactive Voice Response (IVR) based health information for antenatal and postnatal care services in rural Bangladesh
Query!
Scientific title
The effect of Interactive Voice Response (IVR) based health information for antenatal and postnatal care services women of reproductive age group in rural Bangladesh on maternal and child health outcomes
Query!
Secondary ID [1]
304355
0
Laerdal Foundation - 40715
Query!
Universal Trial Number (UTN)
U1111-1268-9094
Query!
Trial acronym
IVRMCH (Interactive Voice Response for maternal and child health)
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pregnancy complications
323328
0
Query!
Condition category
Condition code
Public Health
320891
320891
0
0
Query!
Health promotion/education
Query!
Reproductive Health and Childbirth
325705
325705
0
0
Query!
Antenatal care
Query!
Reproductive Health and Childbirth
325706
325706
0
0
Query!
Normal pregnancy
Query!
Reproductive Health and Childbirth
325707
325707
0
0
Query!
Childbirth and postnatal care
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Description of interventions using the TIDieR (Template for Intervention Description and Replication) Checklist
Brief name/description: This is an interactive voice response (IVR) based health information trial where pregnant women in rural Bangladesh will be provided with information on evidence-based and recommended World Health Organization (WHO) guidelines and the guidelines of Bangladesh following the Ministry of Health and Family Welfare for prenatal and postnatal care services for expectant mothers and their newborn babies.
Why?: Having evidence-based information on maternal and child care will improve maternal and child health outcomes in two ways:
- by improving in knowledge on and practice of maternal and child health care, and
- by improving maternal and child health care seeking
What:
Demonstration: One-hour session on how to access the information using IVR on a mobile phone.
Materials: 15 modules containing pregnancy and postpartum stage-specific information on antenatal and postnatal care, antenatal and postnatal mental health, and taking care of a newborn baby for up to 6 months.
The modules will be recorded in voice-over form and stored using IVR technology. Participants will be able to access this information any time they want.
Tele-health: In one of the intervention arms, tele-health support will be provided by a doctor for common health problems, at participant's own discretion. each call may last up to 15 minutes. This support will be provided for general health problems only where a doctor can provide support without physically examining pregnant women.
Arm 1: IVR + Tele-health – Participants will be able to interact with the messages system using the keypad of their phone and will be able to contact a project doctor to discuss their health and the heath of their babies once they are born.
Arm 2: IVR - Participants will be able to interact with the messages system using the keypad of their phone
Arm 3: Control – N intervention will be given.
Text: Participants will receive one push notification once every two weeks, to encourage them to access information.
Call: Participants will receive push call once every two weeks (following the text message stated above) to encourage them to access information.
Dose: Participants are expected to listen to each IVR module at least once to measure the effect. The duration of each module is about 15 minutes. Participants can listen to the modules as many time they want.
Procedure: Dissemination of maternal and child health information using mobile phone network and IVR.
Who provided:
Demonstration session will be observed by the project staff members who hold a bachelor's degree and have at least five years of experience working in maternal and child health and early childhood development. There will be a doctor to respond to the participants call or answer to their query over the phone in one of the intervention arms.
How:
Demonstration sessions will be conducted face-to-face. The modules will be recorded in voice-over form and stored using IVR technology. Participants will be able to access this information any time they want. Participants will receive push notification to encourage them to access information.
Where:
330 villages in the southwestern part of Bangladesh.
Arm 1: 110
Arm 2: 110
Arm 3: 110
When and how much:
Demonstration session: At the end of baseline 1 session
Modules: 15 modules stored and accessible using IVR
Text: 1 push notifications every two weeks (1 text followed by 1 call, for Arms 1 and 2)
Dose: Participants are expected to listen to each IVR module at least once (1 time) to measure the effect.
Help from doctors: Help from doctor will be available at specific time slots during the day in one of the treatment arms.
Tailoring:
The push notification will be tailored based on whether the participants are in antenatal or postpartum stages and the child’s age (in months).
Modification: N/A
How well:
Planned: Each time an IVR module will be accessed and listened to, the number will be automatically recorded.
Text messages will be sent by a team of project staff members who will be supervised by a team leader.
A senior project staff member will ensure whether IVR modules are accessible by keeping an update, using a log, of accessible modules.
Doctor: Doctor will be given a separate mobile phone with a dedicated number, with field-level monitoring in place.
Actual: If IVR was available to Arm 1 and 2, doctor was accessible via phone, push text and call were made
Query!
Intervention code [1]
321565
0
Prevention
Query!
Intervention code [2]
321566
0
Behaviour
Query!
Comparator / control treatment
The control group will not receive the intervention.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
329569
0
Antenatal Care (ANC) and Postnatal Care (PNC)practice (composite outcome)
1. Number of ANC visits to the doctor/ midwife
2. Number of PNC consultations with doctor/ midwife
Tool: study specific questionnaire about ANC and PNC visits at endline ,
Query!
Assessment method [1]
329569
0
Query!
Timepoint [1]
329569
0
at 6 months postpartum
Query!
Primary outcome [2]
329570
0
Maternal mental health and child caring learning (composite outcome)
1. Awareness about maternal mental health
2, Awareness about nutrition and immunisation of infants and babies
Tool: Study specific questionnaire
Query!
Assessment method [2]
329570
0
Query!
Timepoint [2]
329570
0
at 6 months postpartum
Query!
Primary outcome [3]
329571
0
Health-seeking behaviour from facilities- for mother and child:
1. visiting health facilities/ doctors or consulting doctor for health problems duirng pregnancy and postpartum (up to 6 months) (excluding ANC and PNC visits/ consultations)
2. visiting health facilities/ doctors or consulting doctor for health problems of the infant/ baby (within followup period) (excluding for immunisation)
Tool: Study specific questionnaire
Query!
Assessment method [3]
329571
0
Query!
Timepoint [3]
329571
0
6 months postpartum
Query!
Secondary outcome [1]
402919
0
events of 5 signs of pregnancy complications
Tool: Study-specific questionnaire
Query!
Assessment method [1]
402919
0
Query!
Timepoint [1]
402919
0
At delivery (+ 10 days as the mother may need time to recover and take care of the new baby)
Query!
Secondary outcome [2]
402920
0
Stillbirth
Tool: Patient medical record
Query!
Assessment method [2]
402920
0
Query!
Timepoint [2]
402920
0
at 6 months after delivery
Query!
Secondary outcome [3]
402921
0
the episode of common illnesses among babies
Tool: Study specific questionnaire
Query!
Assessment method [3]
402921
0
Query!
Timepoint [3]
402921
0
6 months of age
Query!
Secondary outcome [4]
402922
0
postnatal infection
Tool: study-specific questionnaire
Query!
Assessment method [4]
402922
0
Query!
Timepoint [4]
402922
0
at 10 days post-delivery
Query!
Secondary outcome [5]
403052
0
Preterm birth
Tool: Patient medical record
Query!
Assessment method [5]
403052
0
Query!
Timepoint [5]
403052
0
at 10 days post-delivery
Query!
Secondary outcome [6]
403053
0
Low birthweight
Tool: Patient medical record
Query!
Assessment method [6]
403053
0
Query!
Timepoint [6]
403053
0
at 10 days post-delivery
Query!
Secondary outcome [7]
403055
0
duration and number of times accessed IVR (composite outcome)
Tool: Platform analystics
Query!
Assessment method [7]
403055
0
Query!
Timepoint [7]
403055
0
6 months postpartum
Query!
Secondary outcome [8]
417532
0
Awareness of ANC and PNC - nutrition, rest, required ANC and PNC visits (composite outcome)
Tool: Study specific questionnaire
Query!
Assessment method [8]
417532
0
Query!
Timepoint [8]
417532
0
6 months after delivery
Query!
Eligibility
Key inclusion criteria
- 15 years old or older up to 49 years
- up to 24 weeks or within the 2nd trimester
- able to give informed consent
Query!
Minimum age
15
Years
Query!
Query!
Maximum age
49
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- below 15 years of age and above 49 years
- not currently pregnant
- pregnant but in their third trimester
- not able to give informed consent
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation at village level. Participants will be recruited between 20 January - 20 March 2023. 8-18 participants will be recruited from each village.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Intention to treat (ITT)
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
20/01/2023
Query!
Actual
21/01/2023
Query!
Date of last participant enrolment
Anticipated
20/03/2023
Query!
Actual
31/03/2023
Query!
Date of last data collection
Anticipated
20/06/2024
Query!
Actual
Query!
Sample size
Target
3900
Query!
Accrual to date
Query!
Final
4107
Query!
Recruitment outside Australia
Country [1]
24321
0
Bangladesh
Query!
State/province [1]
24321
0
Khulna
Query!
Funding & Sponsors
Funding source category [1]
308724
0
Charities/Societies/Foundations
Query!
Name [1]
308724
0
Laerdal Foundation
Query!
Address [1]
308724
0
Laerdal Foundation
P.O. Box 556, Sentrum
4003 Stavanger Norway
Query!
Country [1]
308724
0
Norway
Query!
Funding source category [2]
310761
0
Other Collaborative groups
Query!
Name [2]
310761
0
Asian Development Bank
Query!
Address [2]
310761
0
Bangladesh Resident Mission (BRM) - Asian Development Bank (ADB)
Plot E-31, Sher-e-Bangla Nagar
Dhaka 1207, Bangladesh
GPO Box No. 2100
Query!
Country [2]
310761
0
Bangladesh
Query!
Primary sponsor type
University
Query!
Name
Monash University , Australia
Query!
Address
Centre for Development Economics and Sustainability (CDES)
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]
309623
0
None
Query!
Name [1]
309623
0
None
Query!
Address [1]
309623
0
None
Query!
Country [1]
309623
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
308647
0
Human Research Ethics Committee, Monash University, Australia
Query!
Ethics committee address [1]
308647
0
Wellington Rd, Clayton VIC 3800
Query!
Ethics committee country [1]
308647
0
Australia
Query!
Date submitted for ethics approval [1]
308647
0
14/08/2021
Query!
Approval date [1]
308647
0
12/10/2021
Query!
Ethics approval number [1]
308647
0
29389
Query!
Summary
Brief summary
Despite remarkable improvement in maternal and child health over the last three decades, the maternal mortality rate in Bangladesh stands at an alarming 176 per 100 thousand live births. Neonatal deaths account for 67% of all under-5 deaths in Bangladesh. Lack of availability of quality maternal health care, combined with a low level of health literacy, traditional gender norms, fear of stigma, and cultural beliefs about pregnancy are some of the challenges to ensuring quality maternal healthcare services and thus, safe motherhood in rural areas. This means providing improved care early on could prevent loss of lives and help achieve sustainable development goals around maternal and child health. In this project, we propose to use a village level clustered randomised controlled trial, and experiment with a smart solution based on the most available basic feature phone. We will use a mobile phone-based Interactive Voice Response system along with a virtual call centre. We plan to deliver this information to mothers during their antenatal and postnatal period. Information modules will include pregnancy-stage specific information for expectant mothers and key information on caring for children (up to six months), and information on care facilities available in the area. The information modules will be developed following World Health Organization (WHO) guidelines and the guidelines of Bangladesh following the Ministry of Health and Family Welfare for prenatal and postnatal care services. The main intervention consists of a series IVR based modules to maternal healthcare services to be provided every two weeks during pregnancy, delivery, and the postpartum period. In addition, we will send regular SMS with various key information that will be discussed in the modules. An advisory service will be provided using a toll-free call centre, and reminders for periodic modules and SMS and push call will be designed to remind and nudge.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
111422
0
Prof Asadul Islam
Query!
Address
111422
0
Director, Centre for Development Economics and Sustainability (CDES)
Professor, Department of Economics
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Query!
Country
111422
0
Australia
Query!
Phone
111422
0
+61 3 990 32783
Query!
Fax
111422
0
+61 3 990 31128
Query!
Email
111422
0
[email protected]
Query!
Contact person for public queries
Name
111423
0
Prof Asadul Islam
Query!
Address
111423
0
Director, Centre for Development Economics and Sustainability (CDES)
Professor, Department of Economics
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Query!
Country
111423
0
Australia
Query!
Phone
111423
0
+61 3 990 32783
Query!
Fax
111423
0
+61 3 990 31128
Query!
Email
111423
0
[email protected]
Query!
Contact person for scientific queries
Name
111424
0
Prof Asadul Islam
Query!
Address
111424
0
Director, Centre for Development Economics and Sustainability (CDES)
Professor, Department of Economics
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Query!
Country
111424
0
Australia
Query!
Phone
111424
0
+61 3 990 32783
Query!
Fax
111424
0
+61 3 990 31128
Query!
Email
111424
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
The identified variables will be available upon submitting a request to the Chief Investigator.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14079
Ethical approval
No citation available.
[email protected]
A copy of the pre-analysis plan has been uploaded ...
[
More Details
]
382091-(Uploaded-12-11-2021-23-45-01)-Study-related document.pdf
20695
Statistical analysis plan
Ahmed, F., Islam A., Khalil U., Rahman, T., Suryadarma D. Improving Antenatal and Postnatal Care Delivery Services in Remote Communities using Telehealth: Pre-analysis plan. 2023.
[email protected]
N/A
382091-(Uploaded-01-10-2023-18-24-42)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF