UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046001 |
|---|---|
| Receipt number | R000052428 |
| Scientific Title | Intervention study about the number of days from daily breast stimulation start during pregnancy to labor onset. |
| Date of disclosure of the study information | 2021/11/09 |
| Last modified on | 2023/02/23 18:31:07 |
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Basic information
Public title
Intervention study about the number of days from daily breast stimulation start during pregnancy to labor onset.
Acronym
Study on the number of days from daily breast stimulation pregnancy to labor onset.
Scientific Title
Intervention study about the number of days from daily breast stimulation start during pregnancy to labor onset.
Scientific Title:Acronym
Study on the number of days from daily breast stimulation pregnancy to labor onset.
Region
| Japan |
Condition
Condition
late pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the number of days to labor onset from intervention of breast stimulation which is instructed by gynecological professionals one hour per day from 39 to 40 weeks of pregnant women at 38 weeks gestation.
Basic objectives2
Others
Basic objectives -Others
To clarify the optimal period of starting introduction for health guidance.
To clarify the recommended time of breast stimulation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of days to labor onset from intervention of breast stimulation one hour per day from 39 to 40 weeks of pregnant women .
Key secondary outcomes
The optimal period of starting introduction by gynecological professionals
The recommended time of breast stimulation
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
| Behavior,custom |
Interventions/Control_1
An instruction of nipple-stimulation to pregnant women at 38 weeks 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women of 38 weeks gestation scheduled for vaginal delivery at Kurashiki Central Hospital
Key exclusion criteria
Fetuse pre-scheduled to enter the NICU after delivery
Multiple pregnancy
Abnormal fetal presentation
Fetal growth restriction
Hypertensive disorder of pregnancy
Gestational Diabetes Mellitus
Mental disorder merger
Polyhydramnios
Oligohydramnios
Placenta previa or low-lying placenta
Previous caesarean section
Vaginal birth after uterine artery embolization
Mother's history of intrauterine fetal death
Mother's history of premature separation of normally implanted placenta
Mother who do not speak Japanese
Other cases in which an attending gynecologist determine the patient is ineligible for the present study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Anju |
| Middle name | |
| Last name | NAKAZUMI |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Gynecology
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
ai15766@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Anju |
| Middle name | |
| Last name | NAKAZUMI |
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Division name
Department of Gynecology
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
ai15766@kchnet.or.jp
Sponsor or person
Institute
Ohara Healthcare Foundation, Kurashiki Central Hospital, Department of Gynecology
Institute
Department
Personal name
Funding Source
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ohara Healthcare Foundation, Kurashiki Central Hospital
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
086-422-0210
kenkyu@kchnet.or,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
| 2021 | Year | 11 | Month | 09 | 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
93
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
| 2021 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052428
