UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017911
Receipt number R000020704
Scientific Title Changes in Salivary Oxytocin related to Breast Stimulation for Spontaneous Onset of Labor in Low Risk Pregnant Women: Pilot Study
Date of disclosure of the study information 2015/06/16
Last modified on 2015/08/28 10:16:07

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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: Pilot Study

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: Pilot Study

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

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

1. To examine salivary levels of oxytocin during breast stimulation for spontaneous onset of labor in term pregnancies
2. To confirm the feasibility of the experimental approach

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Salivary oxytocin on 10 minutes before intervention and 15, 30, 60, 75, 90 minutes after intervention

Key secondary outcomes

polymorphisms of oxytocin recepter


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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Conducts breast self-stimulation for three days while in the hospital.
Each breast is individually stimulated for 15 minutes, alternating breasts, for a total of one hour.

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

25 years-old <=

Age-upper limit

35 years-old >=

Gender

Female

Key inclusion criteria

1. Plan to give singleton birth with spontaneous cephalic delivery
2. Between 38 and 40 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. Takes medication related to gestation
2. Medical or pregnancy complications
3. Mental illness
4. Medical history of treatment of Assisted Reproductive Technology
5. BMI above 25 before pregnancy
6. Planned induced labor
7. Experienced prolonged pregnancy
8. Previous caesarian section
9. Breast feeding child

Target sample size

15


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

Email

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


Email

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

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Fumiko Yamaji grant in aid for Nursing research


IRB Contact (For public release)

Organization


Address


Tel


Email



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(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 16 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

2015 Year 06 Month 11 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 16 Day

Last follow-up date

2015 Year 09 Month 15 Day

Date of closure to data entry

2015 Year 09 Month 15 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 15 Day

Last modified on

2015 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020704


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name