Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062562) titled 'Effects of Parenting Guidance for Pregnant Women on Infant Head Turn Preference and Head Shape' on Aug. 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - The University of Tokyo

Condition: Condition - plagiocephaly Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the effects of parental guidance provided to mothers during pregnancy on the degree of head turn preference and plagiocephaly in infants at 1 and 3 months of age. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In the intervention group, researchers will provide guidance before delivery on methods to address the infant's head turn preference, the appropriate frequency of intervention, and safety precautions. In addition, researchers will ask them to keep a record of the time spent on daily exercises to address head turn preference, using an app or a diary book. Interventions/Control_2 - Participants in the control group will not receive prenatal guidance. At the conclusion of the 3-month measurements, they will be given the informational materials distributed to participants in the intervention group.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1) Women with a singleton pregnancy between 28 weeks 0 days and 36 weeks 6 days at the time of study enrollment 2) Individuals who reside or will be staying within approximately one hour's travel time (one way) from the University of Tokyo's Hongo Campus and have no plans to move outside this area by the end of the follow-up period 3) Individuals who consent to home visits by researchers for data collection or who are able to visit a laboratory on the Hongo Campus 4) Women who are pregnant with their first child Key exclusion criteria - 1) Individuals who have difficulty speaking, reading, or writing in Japanese 2) Individuals whose fetus is found to have a clear, severe congenital anomaly 3) Women with multiple pregnancies 4) Individuals whom their attending physician has determined are unsuitable for participation in this study 5) Individuals whose child is of a race other than Japanese Target Size - 112

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 23 Day Date of IRB - 2026 Year 07 Month 23 Day Anticipated trial start date - 2026 Year 08 Month 12 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070719

Disclaimer: Curated by HT Syndication.