UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037783 |
|---|---|
| Receipt number | R000040335 |
| Scientific Title | Impact of the Intrapartum Synthetic Oxytocin Dose on Breastfeeding and Endogenous Oxytocin: Cohort study |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2022/03/04 11:24:32 |
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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
| Obstetrics 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
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
kaoritakahata@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040335
