UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050285 |
|---|---|
| Receipt number | R000045334 |
| Scientific Title | intervention study with non-ramdormised allocation |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2025/02/17 15:37:41 |
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Basic information
Public title
Effect of audit and feedback intervention on quality indicator of childbirth care of low-risk pregnancy
Acronym
Birth care Quality Improvement Project
Scientific Title
intervention study with non-ramdormised allocation
Scientific Title:Acronym
Quasi-experiment study
Region
| Japan |
Condition
Condition
pregnancy and childbirth
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of feedback using quality indicator of care for low-risk pregnant women planning in hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of seven indicators in quality indicator of care for low-risk pregnancy women planning in hospital
Key secondary outcomes
clinical outcome
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Feedback of result measuring quality indicator
The team's efforts to improve health care
Training on quality of care and quality indicators
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Low-risk women without complications or risk factor of high risk factor
Women planning childbirth in a hospital
Women who are able to read and write Japanese
Key exclusion criteria
Preterm delivery < 37 wk
Elective cesarean section before the onset of labor
Women who did not have a prenatal checkup or did not make an appointment for delivery.
A stillbirth diagnosed before hospitalization for delivery.
Follow the definition of each indicator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Ueda |
Organization
Nara medical University/ Kyoto University
Division name
Medical department/ School of Public Health
Zip code
634-8521/ 606-8501
Address
840 Shijo-Cho, Kashihara, Nara, Japan./ Yoshida Konoe-cho, Sakyo-ku, Kyoto city, Kyoto.
TEL
075-753-9477
ueda.kayo.85a@st.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Ueda |
Organization
Nara medical University/ Kyoto University
Division name
Medical department/ School of Public Health
Zip code
634-8521/ 606-8501
Address
840 Shijo-Cho, Kashihara, Nara, Japan./ Yoshida Konoe-cho, Sakyo-ku, Kyoto city, Kyoto.
TEL
075-753-9477
Homepage URL
k-ueda@naramed-u.ac.jp
Sponsor or person
Institute
Health Informatics, School of Public Health, Kyoto University.
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culture,Sports,Science and Technology
Japan Society for the Promotion of Science
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2024 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045334
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-18K17591/
Number of participants that the trial has enrolled
457
Results
We included 288 women pre-intervention and 167 women post-intervention. The spontaneous vaginal delivery indicator showed a significant increase in slope (risk ratio [RR] 1.08, 95% confidence interval [CI]: 1.00-1.16, p<0.05) per month in the main analysis. Secondary analysis showed a significant increase in the administration of uterotonic agents during the third stage of labour (RR 1.19, 95% CI: 1.01-1.41, p<0.05).
Results date posted
| 2025 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The four facilities participated.These facilities included two perinatal medical centres, one general hospital, and one clinic. The two groups were similar in terms of maternal age, primiparity, body mass index, birth weight, and infant sex, with no significant differences observed.
Participant flow
Of the 457 pregnant women who consented to participate in the study, 455 were eligible for data analysis, after excluding two women who were lost to follow-up owing to transfer before delivery.
Adverse events
There were no adverse events to report.
Outcome measures
1. Indicators where higher values are better:
Spontaneous vaginal birth
No perineal tear and no perineorrhaphy
Use of uterotonics preventing postpartum haemorrhage
Exclusive breastfeeding at the time of discharge
Exclusive breastfeeding during the 1-month health examination
2. Indicators where lower values are better:
Labor induction
Second-degree perineal laceration
Postpartum haemorrhage exceeding 500 grams within 2 hours of birth
Admission to the paediatrics department within a week post-birth
Formula supplementation without medical rationale during hospitalization
Women transitioning to care primarily provided by an obstetrician
Episiotomy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045334
