Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062665) titled 'Research on Infant Hip Health and Parenting' on Aug. 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - Developmental dysplasia of the hip
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To provide face-to-face developmental dysplasia of hip (DDH) prevention education to pregnant women and to examine the effectiveness, acceptability, and feasibility of the education program by assessing changes in behavior, intention, knowledge, attitude, and self-efficacy during pregnancy and after childbirth.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - face-to-face education on DDH prevention (approximately 60 min)
Interventions/Control_2 - No treatment
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1. Pregnant women who are between 22 weeks 0 days and 36 weeks 6 days of gestation on the date of the educational program or the corresponding reference date
2. Women who are pregnant with their first child
3. Women aged 18 years or older
4. Women who are able to read, write, and understand Japanese
If the target sample size cannot be achieved, the criterion requiring participants to be pregnant with their first child may be removed.
Key exclusion criteria - 1. Women with multiple pregnancies
2. Women with diseases or disabilities that may make participation in the study difficult (e.g. severe mental disorders, visual or hearing impairments)
3. Women with high-risk pregnancies (e.g. placenta previa, hypertensive disorders of pregnancy, fetal growth restriction)
4. Women whose fetus has been identified by a physician as having a congenital condition (e.g. congenital heart disease, cleft lip and palate, Down syndrome)
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 24 Day
Anticipated trial start date - 2026 Year 08 Month 24 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071740
Disclaimer: Curated by HT Syndication.