NCT05741931

Brief 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 (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.

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
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

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

February 3, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 3, 2023

Last Update Submit

February 14, 2023

Conditions

Keywords

pregnancy monitoringmobile applicationantenatal carematernal and child health

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    During pregnancy

Study Arms (2)

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

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Suffering from chronic diseases that require special pregnancy care
  • It is certain that it cannot give birth normally
  • Unable to operate an android phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Prima D Ratrikaningtyas

    Gadjah Mada University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 23, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share