UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020797 |
|---|---|
| Receipt number | R000024010 |
| Scientific Title | Changes in Salivary Oxytocin related to Breast Stimulation for Spontaneous Onset of Labor in Low Risk Pregnant Women |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2017/03/21 11:22:17 |
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Basic information
Public title
Changes in Salivary Oxytocin related to Breast Stimulation for
Spontaneous Onset of Labor in Low Risk Pregnant Women
Acronym
Changes in Salivary Oxytocin related to Breast Stimulation
Scientific Title
Changes in Salivary Oxytocin related to Breast Stimulation for
Spontaneous Onset of Labor in Low Risk Pregnant Women
Scientific Title:Acronym
Changes in Salivary Oxytocin related to Breast Stimulation
Region
| Japan |
Condition
Condition
Low-risk pregnant women
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine salivary levels of oxytocin during breast stimulation for spontaneous onset of labor in term low-risk pregnant women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin levels 10 minutes before intervention and 30, 60, 75 minutes after intervention
Key secondary outcomes
(1) Delivery outcomes (spontaneous labor/ oxytocin use to induce labor, gestational week of delivery, the length from experiment to birth, delivery mode, oxytocin use to augment labor, length of delivery)
(2) Polymorphisms of oxytocin receptor (i.e., rs53576, rs2254298)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conducts breast self-stimulation for three days.
Each breast is stimulated for 15 minutes, alternating between the breasts to prevent uterine hyperstimulation, for a total of 1 hour per day.
The participants come to the hospital for intervention the first and third intervention day. On the second intervention day, they perform breast stimulation in their home.
Interventions/Control_2
No intervention.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1. Plan to give singleton birth with spontaneous cephalic delivery primipara
2. Between 38 and 39 weeks of gestation
3. Asian and can read and write Japanese
4. Permission to participate in research provided by attending physician or midwife
Key exclusion criteria
1. Medical or pregnancy complications
2. Mental illness
3. Medical history of treatment of Assisted Reproductive Technology
4. BMI above 25 before pregnancy
5. Planned induced labor
6. Currently performs breast stimulation more than 10 minutes per day.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeko Horiuchi |
Organization
St. Luke's International University, Graduate School
Division name
Nursing science, Women's Health & Midwifery
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL
03-3543-6391
Shigeko-horiuchi@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Takahata |
Organization
St. Luke's International University, Graduate School
Division name
Doctoral Programs in Nursing Science
Zip code
Address
3-8-5, Tukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
03-6226-6361
Homepage URL
14dn009@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
MEXT KAKENHI (B)(Grant Number:26293475)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
1. Yamaji Fumiko Nursing Research Fund
2. The Japan Health Foundation
3. Terumo Foundation for Life Sciences and Arts
IRB Contact (For public release)
Organization
Address
Tel
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
堀病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 15 | 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
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 09 | 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
| 2016 | Year | 01 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024010
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
