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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05741931
Other study ID # 485838
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date December 2024

Study information

Verified date February 2023
Source Gadjah Mada University
Contact Restu Pangestuti
Phone +6285741405163
Email restupangestuti@mail.ugm.ac.id
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 216
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gadjah Mada University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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