UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063486 |
|---|---|
| Receipt number | R000072661 |
| Scientific Title | Effects of Midwife-Led Soft Birth Canal Maturation Care for Pregnant Women at 37 Weeks of Gestation or Later on Birth Outcomes |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/11/01 11:02:49 |
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Basic information
Public title
Effects of Midwife-Led Soft Birth Canal Maturation Care for Pregnant Women at 37 Weeks of Gestation or Later on Birth Outcomes
Acronym
Effects of Midwife-Led Soft Birth Canal Maturation Care for Pregnant Women at 37 Weeks of Gestation or Later on Birth Outcomes
Scientific Title
Effects of Midwife-Led Soft Birth Canal Maturation Care for Pregnant Women at 37 Weeks of Gestation or Later on Birth Outcomes
Scientific Title:Acronym
Effects of Midwife-Led Soft Birth Canal Maturation Care for Pregnant Women at 37 Weeks of Gestation or Later on Birth Outcomes
Region
| Japan |
Condition
Condition
Longitudinal Changes in Soft Birth Canal Maturation in Pregnant Women at 37 Weeks of Gestation or Later
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of midwife-led soft birth canal maturation care for pregnant women at 37 weeks of gestation or later on birth outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal changes in cervical ripening over time.
Key secondary outcomes
Association between the final Bishop score and birth outcomes.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the intervention group, midwife-led soft birth canal maturation care will be provided at 37, 38, 39, and 40 weeks of gestation.
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
A total of 30 pregnant women will be enrolled from among those receiving care at the study site during the study period who have singleton pregnancies, uncomplicated pregnancies, and planned vaginal births, provided that their physicians consider them eligible for participation and they provide informed consent.
Participants must meet all the following criteria:
1.Women aged 20 years or older at the time of obtaining informed consent.
2.Women with uncomplicated pregnancies who are planning vaginal birth.
3.Women who wish to have a spontaneous vaginal birth.
4.Women who have received a sufficient explanation of the study, have fully understood its contents, and have provided written informed consent voluntarily.
5.Women deemed eligible for participation by their attending physician.
Key exclusion criteria
1.Women with pregnancy complications or abnormalities, including multiple pregnancies, breech presentation, or placenta previa.
2.Women scheduled for cesarean delivery.
3.Pregnant women younger than 20 years of age.
4.Women with known allergies to any component of the oils used in the study or to food-derived ingredients.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SHOKO |
| Middle name | |
| Last name | KKATO |
Organization
Miyazaki Prefectural Nursing University
Division name
Doctoral Program, Graduate School of Nursing, Miyazaki Prefectural Nursing University
Zip code
880-0929
Address
3-5-1 Manabino, Miyazaki City, Miyazaki Prefecture, Japan
TEL
0985-59-7700
d16001@mpu.ac.jp
Public contact
Name of contact person
| 1st name | SHOKO |
| Middle name | |
| Last name | KATO |
Organization
Miyazaki Prefectural Nursing University
Division name
Graduate School of Nursing, Miyazaki Prefectural Nursing University
Zip code
880-0929
Address
3-5-1 Manabino, Miyazaki City, Miyazaki Prefecture, Japan
TEL
09044201738
Homepage URL
d16001@mpu.ac.jp
Sponsor or person
Institute
Miyazaki Prefectural Nursing University
Institute
Department
Personal name
SHOKO KATO
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyazaki Prefectural Nursing University
Address
3-5-1 Manabino, Miyazaki City, Miyazaki Prefecture, Japan
Tel
0985-59-7700
d16001@mpu.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
東京慈恵会医科大学附属病院 母子医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 01 | Day |
Last modified on
| 2026 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072661
