UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052815 |
|---|---|
| Receipt number | R000059930 |
| Scientific Title | Study on effectiveness of systematic cardio-tocography use in National Maternal and Child Health Center in Cambodia, an implementation research |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2025/05/21 13:40:54 |
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Basic information
Public title
Study on effectiveness of systematic cardio-tocography use in National Maternal and Child Health Center in Cambodia - an explanatory clinical trial
Acronym
Effectiveness of cardio-tocography use in Cambodia
Scientific Title
Study on effectiveness of systematic cardio-tocography use in National Maternal and Child Health Center in Cambodia, an implementation research
Scientific Title:Acronym
Effectiveness of cardio-tocography use in Cambodia
Region
| Asia(except Japan) |
Condition
Condition
Pregnant women with a risk of non-reassuring foetal status
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify whether "CTG reduces acidosis in newborn babies" in the obstetrics department of referral hospital in Cambodia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pH level in umbilical arterial blood less than 7.20
Key secondary outcomes
pH level in umbilical arterial blood less than 7.15
pH level in umbilical arterial blood less than 7.10
Admission rate of newborn baby
Rate of operational deliveries (either assisted vaginal delivery or caesarean section)
Rate of caesarean section
Perinatal mortality rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention period: CTG will be systematically applied from the admission until giving birth.
Contents of the intervention: CTG result will be evaluated by using a guideline issued from the Japanese Society of Obstetrics and Gynecology. The evaluation results will be used to manage the delivery course.
Frequency of the intervention: Either intermittent or continuous application of CTG will be performed. The selection depends on the evaluation result above.
Interventions/Control_2
Control group: No specific interventions are applied. The delivery management procedure is a standard of the National Maternal and Child Health Centre in Cambodia. No systematic use of CTG is conducted.
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
Pregnant women admitted to National Maternal and Child Health Center. Those who are evaluated as moderate risk group using a standard Initial Assessment Sheet in Cambodian Ministry of Health.
Key exclusion criteria
Women in either of the following criteria
- Woman with unconsciousness, respiratory failure, or shock status
- Women already in the second stage of labour at the admission
- Abnormal foetal presentations
- Intra-uterine foetal death
- Multiple pregnancy
- Known foetal malformation
- Known HIV positive
- Obesity (Body-mass index 30 or more)
- Lower body height (less than 140 cm)
- Malformation of pelvis
Target sample size
1110
Research contact person
Name of lead principal investigator
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Matsui |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
Tomogaoka 7-10-2, Suma-ku, Kobe
TEL
078-792-2555
mmatsui@port.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Matsui |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
Tomogaoka 7-10-2, Suma-ku, Kobe
TEL
078-792-2555
Homepage URL
mmatsui@port.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Ethics Committee for Health Research, Cambodia
Address
Lot #80, Samdach Penn Nouth Blvd (289), Khan Toul Kork, Phnom Penh, Cambodia
Tel
855-12-842-442
nouthsarida@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059930
