Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063407) titled 'A study comparing childbirth with and without a single spinal injection for labor pain relief' on Oct. 26.
Study Type:
Observational
Primary Sponsor:
Institute - Gifu University
Condition:
Condition - Vaginal delivery in women with singleton, cephalic pregnancies
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This retrospective observational study aims to evaluate the clinical utility and safety of single-shot spinal analgesia (SAB) for labor analgesia. Maternal and neonatal outcomes, including total labor duration, labor progression, operative vaginal delivery, and maternal adverse events, will be compared between women who received SAB and those who underwent vaginal delivery without neuraxial labor analgesia at Nadeshiko Ladies Hospital. Patient satisfaction will also be assessed using previously collected routine clinical questionnaire data from women who received SAB.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1. Women aged 20 years or older who delivered at Nadeshiko Ladies Hospital between April 1, 2025, and July 31, 2026.
2. Women with singleton, cephalic pregnancies who underwent vaginal delivery at 36 weeks of gestation or later.
3. Women who received single-shot spinal analgesia (SAB) for labor analgesia or women who underwent vaginal delivery without neuraxial labor analgesia, including SAB, epidural analgesia, or combined spinal-epidural analgesia.
Key exclusion criteria - 1. History of previous cesarean delivery.
2. Multiple pregnancy, breech presentation, delivery before 36 weeks of gestation, or intrauterine fetal death.
3. Intrauterine fetal growth restriction or suspected fetal abnormalities identified prenatally.
4. Maternal BMI of 30 kg/m^2 or higher, hypertensive disorders of pregnancy requiring antihypertensive medication, or poorly controlled gestational diabetes mellitus (defined as a 2-hour postprandial blood glucose level of 150 mg/dL or higher).
5. Labor analgesia other than single-shot spinal analgesia, including epidural analgesia, combined spinal-epidural analgesia, or paracervical block.
6. Missing data for the primary outcome.
Target Size - 80
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2026 Year 09 Month 06 Day
Date of IRB - 2026 Year 09 Month 24 Day
Anticipated trial start date - 2026 Year 09 Month 24 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072526
Disclaimer: Curated by HT Syndication.
