Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058519) titled 'A Preliminary Study of an Educational Intervention on the Impact of Sleep Improvement on Glucose Tolerance in Pregnant Women' on March 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - National Center for Child Health and Development
Condition:
Condition - Impaired Glucose Tolerance
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the potential efficacy and safety of sleep improvement for pregnant women with poor sleep quality in improving glucose tolerance.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Two online meetings and self-study within 4 weeks
Interventions/Control_2 - No specific intervention will be implemented during the 4-week period.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - Ability to communicate in Japanese
Singleton pregnancy
Early pregnancy (first trimester)
Meeting at least one of the following criteria for high risk of impaired glucose tolerance in pregnancy:
a. Family history of diabetes (parents or siblings)
b. History of gestational diabetes mellitus
c. Obesity (BMI over 24)
d. Hypertension
Key exclusion criteria - Participation is deemed inadvisable by a physician due to the participant's physical or mental health condition.
Target Size - 6
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 06 Month 07 Day
Date of IRB - 2024 Year 07 Month 10 Day
Anticipated trial start date - 2024 Year 08 Month 01 Day
Last follow-up date - 2026 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066914
Disclaimer: Curated by HT Syndication.
