UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055936 |
|---|---|
| Receipt number | R000063921 |
| Scientific Title | Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial. |
| Date of disclosure of the study information | 2024/10/24 |
| Last modified on | 2026/02/10 10:06:38 |
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Basic information
Public title
Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial.
Acronym
Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial.
Scientific Title
Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial.
Scientific Title:Acronym
Development of Cognitive Behavioral Therapy-based Midwifery Care for Anxiety in High-Risk Preterm Pregnant Women: A Pilot Randomized Controlled Trial.
Region
| Japan |
Condition
Condition
High-risk Pregnant Women Diagnosed with Threatened Premature Labor, Cervical Incompetency, Premature Rupture of the Membranes, Placenta Previa, Threatened Uterine Rupture, Hypertensive Disorders of Pregnancy and Fetal Growth Restriction
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the feasibility and effectiveness of a cognitive behavioral therapy -based midwifery care program for anxiety in high-risk preterm pregnant women in a pilot randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in State-Trait Anxiety Inventory (STAI) scores before and after the midwifery care intervention is calculated as the mean difference between the two groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will be receiving the midwifery care program. This care program comprises six individual 30-minute sessions addressing perinatal-specific anxiety during pregnancy and the first month postpartum. The program is based on standard midwifery care models, such as antenatal education, birth planning, and birth review, and incorporates CBT elements such as psychoeducation, cognitive restructuring, coping with stress and behavioral activation. It focuses on anxiety regarding preterm birth and aims to promote positive acceptance of one's own birthing experiences that lead to preterm birth.
Interventions/Control_2
The control group will be offered usual care.
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
This study will include only singleton pregnancies. Upon admission, the pregnant woman must be between 24 and 35 weeks' gestation. Additionally, fetal well-being has been confirmed.
Key exclusion criteria
This study will exclude pregnant women with psychiatric complications, multiple gestations, fetal diseases, or who are unable to communicate in Japanese.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Tanii |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Nursing Department
Zip code
276-8524
Address
477-96 Owada Shinden, Yachiyo City, Chiba Prefecture
TEL
047-450-6000
tanii.chie@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tanii |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Nursing Department
Zip code
276-8524
Address
477-96 Owada Shinden, Yachiyo City, Chiba Prefecture
TEL
047-450-6000
Homepage URL
tanii.chie@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
8-1, Kawatachou,Shinjuku-ku,Tokyo
Tel
0333538111
tanii.chie@twmu.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
| 2024 | Year | 10 | Month | 24 | 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
80
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
| 2024 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063921
