UMIN-CTR Clinical Trial

Basic information
Public title	Impact of the Intrapartum Synthetic Oxytocin Dose on Breastfeeding and Endogenous Oxytocin: Cohort study
Acronym	Impact of the Intrapartum Synthetic Oxytocin Dose on Breastfeeding
Scientific Title	Impact of the Intrapartum Synthetic Oxytocin Dose on Breastfeeding and Endogenous Oxytocin: Cohort study
Scientific Title:Acronym	Impact of the Intrapartum Synthetic Oxytocin Dose on Breastfeeding
Region	Japan

Condition
Condition	Low-risk primipara
Classification by specialty	Obsterics and gynecology Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the impact of synthetic oxytocin dose on the lactation secretion at 3 days, 1 month, 4 months after puerperium and salivary oxytocin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	24 hour milk production on postpartum day 3 and 1 month later
Key secondary outcomes	Salivary oxytocin on postpartum day 3 Postpartum 3 days, 1 and 4 months later breastfeeding continuation rate Start date of Lactogenesis II

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	43 years-old >
Gender	Female
Key inclusion criteria	Singleton primiparas who plan on continuing breastfeeding for 12 weeks or more after delivery (including mixed feeding)
Key exclusion criteria	1) Cesarean delivery 2) Medical or pregnancy complications (hypertensive disorders of pregnancy, gestational diabetes (more than 2 points), uterine anomalies) 3) History of breast surgery 4) History of mental illness, epilepsy, cancer 5) Taking or inhaling steroids 6) HTLV, HIV, HBV, HCV positive 7) Smoker 8) Alcoholism 9) Illegal drug users 10) Bleeding in mouth (Periodontal disease, bleeding gums, stomatitis) 11) When epidural anesthesia is delivered without using synthetic oxytocin 12) Preterm birth (giving birth before 37 weeks of pregnancy) 13) Birth weight of less than 2500g 14) Oral anomalies in newborns 15) Apgar score of less than 7 at birth in newborns 16) Neonatal admission to NICU
Target sample size	165

Research contact person
Name of lead principal investigator	1st name Kaori Middle name Last name Takahata
Organization	St. Luke's International University, Graduate School
Division name	Nursing science
Zip code	104-0044
Address	10-1, Akashi-cho, Chuo-ku, Tokyo
TEL	03-3543-6391
Email	kaoritakahata@slcn.ac.jp

Public contact
Name of contact person	1st name Kaori Middle name Last name Takahata
Organization	St. Luke's International University, Graduate School
Division name	Nursing science
Zip code	104-0044
Address	10-1, Akashi-cho, Chuo-ku, Tokyo
TEL	03-3543-6391
Homepage URL
Email	kaoritakahata@slcn.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

Funding Source
Organization	Pigeon Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Luke's International University
Address	10-1, Akashi-cho, Chuo-ku, Tokyo
Tel	03-3543-6391
Email	kenkyukikaku@luke.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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	95
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	2019 Year 04 Month 20 Day
Date of IRB	2019 Year 02 Month 07 Day
Anticipated trial start date	2019 Year 09 Month 30 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Evaluation at 3 time points on the 3rd day after delivery, 1 month later, 4 months later 3-4 days after delivery Saliva collection, questionnaire survey, breast observation Record of breast fullness and 24-hour lactation volume 1 month later Questionnaire survey, record of 24-hour lactation volume 4 months later Questionnaire survey

Management information
Registered date	2019 Year 08 Month 23 Day
Last modified on	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040335