Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062846) titled 'Labor analgesia and distress during procedures after vaginal birth' on Sept. 14.

Study Type: Observational

Primary Sponsor: Institute - Kitasato University

Condition: Condition - Physical and psychological distress associated with procedures after vaginal delivery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the Postpartum Procedure Global Distress Score (PPGDS) between women with effective neuraxial labor analgesia at the time of postpartum procedures and women receiving standard care without neuraxial labor analgesia, among women undergoing procedures including perineal, vaginal, or cervical suturing after vaginal delivery. Associations with pain, discomfort, fear, anxiety, loss of control, embarrassment and dignity, procedural ease, additional analgesia, procedure interruptions, blood loss, and complications will also be explored. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old

Gender - Female Key inclusion criteria - Pregnant women aged 18 years or older at consent who meet the following criteria: gestational age of 35 weeks 0 days to 37 weeks 6 days and planned delivery at Kitasato University Hospital; no regular labor contractions, or awaiting planned induction without severe pain and able to understand the study explanation; singleton pregnancy with vaginal delivery planned or considered acceptable; ability to understand the study and complete questionnaires in Japanese; and provision of written informed consent. The primary analysis includes those who deliver vaginally at 37 weeks 0 days or later, undergo target procedures including perineal, vaginal, or cervical suturing, and provide PPGDS data. Key exclusion criteria - Withdrawal of consent after enrollment; cesarean delivery; delivery before 37 weeks 0 days; no target postpartum procedure such as perineal, vaginal, or cervical suturing after vaginal delivery (these participants are counted in the consented cohort and participant flow); immediate postpartum patient-reported outcome assessment judged ethically or medically inappropriate by the principal investigator or attending physician because of stillbirth or deterioration in maternal or neonatal condition; inability to complete the questionnaire within the assessment window because of postpartum hemorrhage, impaired consciousness, emergency surgery, or similar circumstances; or anesthesia/procedures not comparable with routine delivery-room procedures, such as general anesthesia, spinal anesthesia, or complex repair in an operating room. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 03 Day Date of IRB - 2026 Year 07 Month 27 Day Anticipated trial start date - 2026 Year 09 Month 13 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071947

Disclaimer: Curated by HT Syndication.