UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051932 |
|---|---|
| Receipt number | R000058801 |
| Scientific Title | Digital innovations to improve pregnancy and childbirth outcomes in the Pwani Region, Tanzania |
| Date of disclosure of the study information | 2023/08/18 |
| Last modified on | 2025/03/04 19:31:07 |
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Basic information
Public title
Digital innovations to improve pregnancy and childbirth outcomes in the Pwani Region, Tanzania
Acronym
Digital innovations to improve pregnancy and childbirth outcomes
Scientific Title
Digital innovations to improve pregnancy and childbirth outcomes in the Pwani Region, Tanzania
Scientific Title:Acronym
Digital innovations to improve pregnancy and childbirth outcomes
Region
| Africa |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility, usability and impacts of implementing iCTG and Smartphone App during pregnancy at health centers and mobile antenatal care clinics in the Pwani Region, Tanzania.
The purpose of this study is to evaluate the feasibility, usability, and impacts of implementing iCTG and Smartphone App during labor at district hospitals in the PwaniRegion, Tanzania.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is a measure of ANC attendance assessed via the proportion of women who achieved more than four visits .
The primary outcome measure of this study is the caesarean section rate.
Key secondary outcomes
Facility-based delivery in both arms, Detection of abnormal FHR, Cases transferred, Number of lives saved, Perinatal mortality
Perinatal mortality,Cases transferred to a higher-level facility, Preterm birth (less than 37 completed weeks, less than 34 completed weeks, less than 28 completed weeks), Emotional distress: Depression Anxiety and Stress Scale, DASS-21, Apgar less than seven and four at five minutes, Admission to neonatal special care unit or intensive care unit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Study participants with 32 weeks gestational age will be subjected to examination with iCTG every time they come for an antenatal check-up. Additionally, healthcare providers will install a smartphone App that will be used to deliver health education messages to pregnant women.
Continuous electronic fetal monitoring using an iCTG device will be conducted during labour by midwives and obstetricians trained in its use.
Interventions/Control_2
Receive a normal antenatal check-up.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Those who have at least 32 weeks of gestation.
2.Those who reside in the selected district.
3.Those who come for ANC at either facility or a mobile clinic at least once.
4.Individuals who can provide written consent to participate in this study.
5.Those who are literate in Kiswahili or English.
1.Those who are 18 years or older.
2.Those who are literate in Kiswahili or English.
3.Those who have a singleton fetus in cephalic presentation.
4.Individuals who can provide written consent.
Key exclusion criteria
1. Those who are planning a caesarean birth or require a caesarean due to placenta previa or vasa previa
2. Those who are contraindications for the use of a fetal scalp electrode
3. Those who have known fetal structural or functional cardiac conditions.
Target sample size
2069
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Global Health Nursing
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima, Japan
TEL
082-257-5345
yokoshim@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Dorkasi |
| Middle name | Lushindiho |
| Last name | Mwakawanga |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Global Health Nursing
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima, Japan
TEL
082-257-5345
Homepage URL
dorkasmwakawanga@gmail.com
Sponsor or person
Institute
Muhimbili University of Health and Allied Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Medical Research Tanzania
Address
3 Barack Obama Drive, P.O.Box9653,11101 Dar es Salaam,Tanzania.
Tel
+255-22-212-1400
info@nimr.or.tz
Secondary IDs
Secondary IDs
YES
Study ID_1
C2023-0008
Org. issuing International ID_1
Hiroshima University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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 | 04 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058801
