Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062099) titled 'The Association between Preoperative Fasting in Mothers Undergoing Elective Caesarean Section and Neonatal Hypoglycaemia' on July 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Social Medical Corporation Yuuai-kai, Yuuai Medical Center

Condition: Condition - History of cesarean section, neonatal hypoglycemia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objectives of this study are to clarify the impact of differences in maternal preoperative fasting management on the incidence of neonatal hypoglycemia and to compare and evaluate preoperative management strategies that promote physical and psychological comfort for both the mother and the newborn. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Upon admission, patients are randomly assigned to either the diet and fluid intake group or the oral rehydration solution group. Interventions/Control_2 - Measure insulin and blood glucose levels in the mother and umbilical cord blood upon entering the operating room

Eligibility: Age-lower limit - Not applicable Age-upper limit - 1 days-old > Gender - Male and Female Key inclusion criteria - Pregnant women at our hospital undergoing elective cesarean sections without complications (breech presentation, history of previous cesarean sections, concurrent uterine fibroids, use of anticoagulants) and their newborns (full-term) Key exclusion criteria - (1) Emergency cesarean section (2) Gestational diabetes mellitus (GDM) (3) Hypertensive disorders of pregnancy (HDP) (4) Preterm infants (5) Low birth weight infants (6) Thyroid disorders (select only cases with well-controlled disease and a history of outpatient care) (7) Other cases deemed inappropriate by the principal investigator Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 22 Day Date of IRB - 2026 Year 01 Month 28 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2027 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070857

Disclaimer: Curated by HT Syndication.