Maternal and Child HealthNCT05741931
Pregnancy Monitoring Using Mobile Application
A study testing mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting) in people with Maternal and Child Health, run by Gadjah Mada University.
Trial summary
The goal of this Randomized Controlled Trial is to compare the health condition of pregnant women through pregnancy monitoring in the implementation of pregnancy class. The main question it aims to answer are: How is the condition of the mother and baby after pregnancy monitoring using the REST mobile application… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal and Child Health
- What is being tested?
- mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Dec 2024
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women with a gestational age of 20-22 weeks.
- Pregnant women who have a pregnancy check-up at a health facility
- Plan to settle in the research area for at least the next 2 years
- Willing to participate in the research by signing an informed consent form.
Who cannot join
- Suffering from chronic diseases that require special pregnancy care
- It is certain that it cannot give birth normally
- Unable to operate an android phone
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Monitoring Pregnant Women Using REST Mobile Application (Risk Identification, Evaluation Counseling, Systematic Monitoring, Troubleshooting)
The goal of this Randomized Controlled Trial is to compare the health condition of pregnant women through pregnancy monitoring in the implementation of pregnancy class. The main question it aims to answer are:
How is the condition of the mother and baby after pregnancy monitoring using the REST mobile application (Risk identification, Evaluation counseling, Systematic monitoring, Trobleshooting)
Read more
Participants will be monitored for the condition of their pregnancy from 20 weeks of pregnancy until delivery. Participants will attend in the pregnancy class as many as 3 meetings and a pregnancy check-up by the midwife.
Researchers will compare intervention group to see if normal delivery methods, birth weight of the baby (>2500), antenatal care visits (>6 times), and prevention of pregnancy complications were better than the control group.
Read the detailed description
The research will involve pregnant women and midwives. The midwife will conduct a pregnancy check-up which includes 10 pregnancy checks (height and weight, blood pressure, upper arm circumference, uterine fundus height, Tetanus immunization, Fe tablets, fetal presentation and fetal heart rate, counseling, laboratory tests, case handling). The examination is carried out every class meeting of pregnant women. The results of the examination will be inputted into the mobile application. Pregnant women will fill in the mobile application if the mother does antenatal care at a health facility. This activity will last until the mother's delivery.
- Conditions
- Maternal and Child Health
- Being tested
- mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)
- Keywords
- pregnancy monitoring, mobile application, antenatal care, maternal and child health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)Device
The mobile application will be installed on the mobile phone. The application is used to monitor pregnant women. Users of the application are midwives and pregnant women. The application contains documentation of the health condition of pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Pregnant women and midwives will use the REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting) mobile application to monitor the condition of maternal pregnancy. Mothers and midwives will implementation 3 times of pregnancy class until mothers give birth Receives: Device: mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting) |
| Control Group | No intervention | Pregnant women and midwives will conduct pregnancy monitoring as usual. The pregnancy class will be implemented in accordance with government program standards. Mothers will take pregnancy class 3 times until the mother gives birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced incidence of pregnancy complications in the mother
Pregnancy complications are measured using a mobile application by looking at the history of the mother's health condition. Possible complications such as pre-eclampsia, eclampsia, hypertension in pregnancy, and anemia
Measured: 20 weeks gestational age until delivery
Increased childbirth by normal methods
The delivery method can be seen using the mobile application in the labor report section. Delivery will be reported by the midwife regarding the method used for childbirth including the results of filling out the partograph
Measured: 20 weeks gestational age until delivery
Reduced incidence of low birth weight babies
The baby's birth weight is measured using baby scales and it is expected that the baby's birth weight is more than 2500 grams
Measured: 20 weeks gestational age until delivery
Antenatal care for pregnant women more than 6 visits
Antenatal care by mothers can be measured by the number of visits to health facilities for pregnancy check-ups. Each visit will be recorded on the mobile application starting from the first visit
Measured: During pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (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 Maternal and Child HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Restu Pangestuti, Gadjah Mada University
- Investigators
- Prima D Ratrikaningtyas, Study chair, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741931
- Sponsor's protocol ID
- 485838
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pangestuti R, Ratrikaningtyas PD, Sutomo AH. Monitoring of Pregnant Women Using the "Risk Identification, Evaluation Counseling, Systematic Monitoring, Troubleshooting" (REST) Mobile App: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 6;14:e66774. doi: 10.2196/66774.
PubMed 40768267
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Pregnant Women Using REST Mobile Application (Risk Identification, Evaluation Counseling, Systematic Monitoring, Troubleshooting)
- ClinicalTrials.gov ID
- NCT05741931
- Acronym / sponsor ID
- 485838
- Conditions
- Maternal and Child Health
- Keywords
- pregnancy monitoring, mobile application, antenatal care, maternal and child health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Feb 2023 (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 goal of this Randomized Controlled Trial is to compare the health condition of pregnant women through pregnancy monitoring in the implementation of pregnancy class. The main question it aims to answer are:
How is the condition of the mother and baby after pregnancy monitoring using the REST mobile application (Risk identification, Evaluation counseling, Systematic monitoring, Trobleshooting)
Participants will be monitored for the condition of their pregnancy from 20 weeks of pregnancy until delivery. Participants will attend in the pregnancy class as many as 3 meetings and a pregnancy check-up by the midwife.
Researchers will compare intervention group to see if normal delivery methods, birth weight of the baby (>2500), antenatal care visits (>6 times), and prevention of pregnancy complications were better than the control group.
Detailed description
The research will involve pregnant women and midwives. The midwife will conduct a pregnancy check-up which includes 10 pregnancy checks (height and weight, blood pressure, upper arm circumference, uterine fundus height, Tetanus immunization, Fe tablets, fetal presentation and fetal heart rate, counseling, laboratory tests, case handling). The examination is carried out every class meeting of pregnant women. The results of the examination will be inputted into the mobile application. Pregnant women will fill in the mobile application if the mother does antenatal care at a health facility. This activity will last until the mother's delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)Pregnant women and midwives will use the REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting) mobile application to monitor the condition of maternal pregnancy. Mothers and midwives will implementation 3 times of pregnancy class until mothers give birth |
| Control Group | No intervention | –Pregnant women and midwives will conduct pregnancy monitoring as usual. The pregnancy class will be implemented in accordance with government program standards. Mothers will take pregnancy class 3 times until the mother gives birth |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women with a gestational age of 20-22 weeks.
- Pregnant women who have a pregnancy check-up at a health facility
- Plan to settle in the research area for at least the next 2 years
- Willing to participate in the research by signing an informed consent form.
Key exclusion criteria (3 listed)
- Suffering from chronic diseases that require special pregnancy care
- It is certain that it cannot give birth normally
- Unable to operate an android phone
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 |
|---|---|---|
| mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)The mobile application will be installed on the mobile phone. The application is used to monitor pregnant women. Users of the application are midwives and pregnant women. The application contains documentation of the health condition of pregnant women. | Device | Intervention Group |
Primary outcome
Reduced incidence of pregnancy complications in the mother
Time frame: 20 weeks gestational age until delivery
Pregnancy complications are measured using a mobile application by looking at the history of the mother's health condition. Possible complications such as pre-eclampsia, eclampsia, hypertension in pregnancy, and anemia
Increased childbirth by normal methods
Time frame: 20 weeks gestational age until delivery
The delivery method can be seen using the mobile application in the labor report section. Delivery will be reported by the midwife regarding the method used for childbirth including the results of filling out the partograph
Reduced incidence of low birth weight babies
Time frame: 20 weeks gestational age until delivery
The baby's birth weight is measured using baby scales and it is expected that the baby's birth weight is more than 2500 grams
Antenatal care for pregnant women more than 6 visits
Time frame: During pregnancy
Antenatal care by mothers can be measured by the number of visits to health facilities for pregnancy check-ups. Each visit will be recorded on the mobile application starting from the first visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 40768267Pangestuti R, Ratrikaningtyas PD, Sutomo AH. Monitoring of Pregnant Women Using the "Risk Identification, Evaluation Counseling, Systematic Monitoring, Troubleshooting" (REST) Mobile App: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 6;14:e66774. doi: 10.2196/66774.
- Individual participant dataSharing planned: No
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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.
Prima D Ratrikaningtyas study chair
Gadjah Mada University
Questions about this trial
What is this clinical trial studying?
A study testing mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting) in people with Maternal and Child Health, run by Gadjah Mada University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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 23 Feb 2023. 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 Restu Pangestuti (+6285741405163, restupangestuti@mail.ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced incidence of pregnancy complications in the mother (time frame: 20 weeks gestational age until delivery). The study lists 4 primary outcomes in all. 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 NCT05741931, 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 23 Feb 2023.