UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in Salivary Oxytocin related to Breast Stimulation for Spontaneous Onset of Labor in Low Risk Pregnant Women
Title of the study (Brief title)	Changes in Salivary Oxytocin related to Breast Stimulation
Region	Japan

Condition
Condition	Low-risk pregnant women
Classification by specialty	Obsterics 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	Shigeko Horiuchi
Organization	St. Luke's International University, Graduate School
Division name	Nursing science, Women's Health & Midwifery
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	Kaori Takahata
Organization	St. Luke's International University, Graduate School
Division name	Doctoral Programs in Nursing Science
Address	3-8-5, Tukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-6226-6361
Homepage URL
Email	14dn009@slcn.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024010