UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060472 |
|---|---|
| Receipt number | R000069177 |
| Scientific Title | Evaluation of the Add-on Effect of Acupuncture to Standard Care for Minor Postpartum Troubles in a Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/27 21:14:51 |
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Basic information
Public title
A Study to Examine the Effects of Adding Acupuncture to Standard Care for Postpartum Discomforts
Acronym
Evaluation of the Additional Benefits of Acupuncture for Postpartum Discomforts Compared with Standard Care
Scientific Title
Evaluation of the Add-on Effect of Acupuncture to Standard Care for Minor Postpartum Troubles in a Randomized Controlled Trial
Scientific Title:Acronym
Randomized Controlled Trial of the Add-on Effect of Acupuncture for Postpartum Minor Troubles
Region
| Japan |
Condition
Condition
Postpartum minor physical and psychological symptoms
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An efficacy evaluation trial
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of symptoms assessed by the Visual Analogue Scale (VAS) for minor troubles
Key secondary outcomes
Severity of postpartum depression assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Standard care routinely provided (including analgesics, gastrointestinal medications, breast care, pelvic care, stretching guidance, use of compression stockings, and Kampo prescriptions)
Interventions/Control_2
Acupuncture
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
| 18 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
Women who were deemed eligible for participation in the study by a physician after childbirth
Key exclusion criteria
Women who had a cesarean delivery; those with postpartum hypertensive disorders or severe complications; those with allergies to acupuncture or who showed refusal reactions to acupuncture; and those who were transferred to another hospital or transported to another facility
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Tsujiuchi |
Organization
Serie Acupuncture and Moxibustion Clinic
Division name
Clinical Practice Department
Zip code
2310063
Address
704, 1-5 Hanasaki-cho, Naka-ku, Yokohama, Kanagawa, Japan
TEL
0452625550
t-serie@serie89.com
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kanai University of Health Sciences
Division name
Graduate School
Zip code
590-0482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan=gun, Osaka, Japan
TEL
0724538251(2863)
Homepage URL
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Kanai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kanai University of Health Sciences
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
SEIRIN Corporation
IRB Contact (For public release)
Organization
Ethics Committee of Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori-cho, Sennan=gun, Osaka, Japan
Tel
0724538251
kyoumu@kansai.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
| 2026 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Results will be published in a peer-reviewed journal
Publication of results
Published
Result
URL related to results and publications
Results will be published in a peer-reviewed journal
Number of participants that the trial has enrolled
72
Results
Seventy-two participants were recruited, and 65 were analyzed (33 in the standard care group and 32 in the acupuncture add-on group), with no significant baseline differences. The acupuncture add-on group showed significant improvements in fatigue, lack of restful sleep, perceived insufficient breast milk secretion, and breast engorgement on the VAS. No significant difference in EPDS scores was observed between the groups (P = 0.108 OR3.75).
Results date posted
| 2026 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences between the two groups in baseline characteristics, including age, parity, gestational age, mode of delivery, and support systems, among the 65 analyzed participants.
Participant flow
Seventy-two participants were recruited, and 7 were excluded, leaving 65 participants for randomization. Participants were allocated to the standard care group (n = 33) or the acupuncture add-on group (n = 32). There were no participants lost to follow-up in either group. No participants were excluded from the analysis, and all randomized participants (n = 65) were included in the final analysis.
Adverse events
No adverse events were observed in the usual care group.
In the acupuncture plus usual care group, 12 minor adverse events were reported across a total of 128 treatment sessions, including needling pain (n = 5), discomfort at the insertion site (n = 3), minor bleeding (n = 1), and fatigue (n = 1).
All adverse events were transient, and no serious adverse events were observed in either group.
Outcome measures
Effects on postpartum minor troubles assessed by VAS (11 items): hemorrhoids/anal pain, shoulder stiffness, fatigue, lack of restful sleep, breast engorgement, perceived insufficient breast milk secretion, perineal pain, edema, pelvic pain, low back pain, and coldness.
Edinburgh Postnatal Depression Scale (EPDS).
Plan to share IPD
Individual participant data collected in this study will not be shared with other researchers due to ethical considerations and the protection of participant privacy.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069177
| Research Plan | |
|---|---|
| Registered date | File name |
| 2026/01/27 | 解析計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2026/01/27 | 研究症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2026/01/27 | 研究症例データ.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/69177
