UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050274 |
|---|---|
| Receipt number | R000057246 |
| Scientific Title | Detection alarm to postpartum emergency based on IoT |
| Date of disclosure of the study information | 2023/02/08 |
| Last modified on | 2023/11/17 13:41:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Detection alarm to postpartum emergency based on IoT
Acronym
Detection alarm to postpartum emergency based on IoT
Scientific Title
Detection alarm to postpartum emergency based on IoT
Scientific Title:Acronym
Detection alarm to postpartum emergency based on IoT
Region
| Asia(except Japan) |
Condition
Condition
Emergency conditions can occur in uncertain conditions in the postpartum period so that continuous health monitoring is needed at home because in general postpartum women have been discharged from health facilities so innovation is needed in health monitoring at least vital signs connected to the internet known as the Internet of things (IoT). If there is a serious medical problem the midwife can help make a decision or if the problem is not serious, preventive measures can be taken.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Knowing the level of accuracy of diagnosis, speed of diagnosis, accuracy of giving solutions using measurements of blood pressure, pulse and oxygen saturation in solving post partum emergency problems using the internet of things.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The use of sensor-based measuring devices using the internet of things is accurate and fast in assessing pulse, blood pressure, and oxygen saturation measurements for postpartum emergency detection and the accuracy of providing solutions as early warning systems.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
a. Postpartum mother
b. The mother who has been cared for at home
c. Mothers with a history of normal delivery
d. Mothers with a history of high risk during pregnancy
e. Mothers with a history of high-risk delivery
f. Willing to be a respondent
Key exclusion criteria
a. Postpartum mothers with a history of cesarean delivery
b. Not willing to join this research.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fitri |
| Middle name | |
| Last name | Cicilia |
Organization
Poltekkes Kemenkes Semarang
Division name
Master of Applied Midwifery
Zip code
50268
Address
Jalan Tirto Agung, Pedalangan, Kecamatan Banyumanik
TEL
081340013565
bidanfitricicilia@gmail.com
Public contact
Name of contact person
| 1st name | Poltekkes |
| Middle name | Kemenkes |
| Last name | Semarang |
Organization
Poltekkes Kemenkes Semarang
Division name
Master of Applied Midwifery
Zip code
50268
Address
Jalan Tirto Agung, Pedalangan, Kecamatan Banyumanik, Kota Semarang, Jawa Tengah, Indonesia
TEL
0247460274
Homepage URL
bidanfitricicilia@gmail.com
Sponsor or person
Institute
Poltekkes Kemenkes Semarang
Institute
Department
Personal name
Funding Source
Organization
Poltekkes Kemenkes Semarang
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Poltekkes Kemenkes Semarang
Address
Jalan Tirto Agung, Pedalangan, Kecamatan Banyumanik, Kota Semarang, Jawa Tengah, Indonesia
Tel
(024) 7460274
bidanfitricicilia@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Poltekkes Kemenkes Semarang
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
The design used in this research is observational research with a one shot case study approach. Hardware technology that uses sensors and is connected to the internet (IoT) is used to measure pulse rate, blood pressure and oxygen levels in the blood. This measurement is carried out accurately and quickly to detect emergency conditions after delivery. The results of these measurements are then used to provide solutions or early warnings with a good level of accuracy. This entire system aims to detect postnatal emergencies quickly and provide effective solutions. Then the results are compared with the results of manual measurements to assess the level of accuracy of the design tool measurements.
Management information
Registered date
| 2023 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057246
