Pregnancy Monitoring Using Mobile Application

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Maternal and Child Health
• Intervention / Treatment: Device: mobile application REST (Risk identification, Evaluation counseling, Systematic monitoring, Troubleshooting)

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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Restu Pangestuti; Phone Number: +6285741405163; Email: restupangestuti@mail.ugm.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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); 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.
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gadjah Mada University
• Investigators: Study Chair: Prima D Ratrikaningtyas, Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2023
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Estimate): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: maternal and child health; antenatal care; mobile application; pregnancy monitoring
• Other Study ID Numbers: 485838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No