UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061254 |
|---|---|
| Receipt number | R000069453 |
| Scientific Title | Impact of Social Support on Postpartum Recovery |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/14 12:39:04 |
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Basic information
Public title
Impact of Social Support on Postpartum Recovery
Acronym
Impact of Social Support on Postpartum Recovery
Scientific Title
Impact of Social Support on Postpartum Recovery
Scientific Title:Acronym
Impact of Social Support on Postpartum Recovery
Region
| Japan | North America |
Condition
Condition
postpartum woman
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the relationship between social support and postpartum recovery.
Basic objectives2
Others
Basic objectives -Others
1) Assess changes in social support over time postpartum
2) To psychometrically evaluate the STORK-Japanese patient-reported outcome measure
3) Determine the minimal clinically important difference (MCID) for ObsQoR10
4) Determine the MCID for STORK
5) To psychometrically evaluate the PICSS-Japanese measure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relationship between social support and postpartum recovery
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Japanese-speaking women (in Japan) more than 18 years of age who are also able to read and understand written Japanese
Cesarean and spontaneous vaginal delivery
Any parity
Any gestational age
Any anaesthesia type
Key exclusion criteria
Age < 18 years
Women whose infants have died
Patient refusal to participate
Inability to read or understand written Japanese
Instrumental deliveries
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Noguchi |
Organization
Center for Maternal-Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University
Division name
Department of Obstetric Anesthesiology
Zip code
350-0844
Address
1981 Kamoda Kawagoe Saitama
TEL
049-228-3400
noguchi.shohei.521@1985.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kosaka |
| Middle name | |
| Last name | Iwayama |
Organization
Center for Maternal-Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University
Division name
Department of Obstetric Anesthesiology
Zip code
350-0844
Address
1981 Kamoda Kawagoe Saitama
TEL
049-228-3400
Homepage URL
kosaka.19820407@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Kosaka YABUKI
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Belgium
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Maternal-Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University
Address
1981 Kamoda Kwagoe Saitama
Tel
049-228-3400
kosaka.19820407@gmail.com
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 | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No additional Information.
Management information
Registered date
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069453
