Clinical Trial

Fixed-Interval vs. On-Demand Analgesia After Vacuum-Assisted Delivery: RCT

Completed
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Summary
This randomized controlled trial evaluates the effectiveness of scheduled versus on-demand pain relief protocols in managing postpartum pain during the first 24 hours after vacuum-assisted delivery. Objectives: Primary: Compare pain reduction (VAS scores) between the two protocols. Secondary: Assess extended pain relief use, breastfeeding rates, maternal satisfaction, and postpartum hospitalization duration. Design: Participants: 200 women aged 18-45, randomized into two groups: Scheduled Pain Relief: Acetaminophen and diclofenac every 8 hours. On-Demand Pain Relief: Same medications administered upon request. Pain levels are assessed via VAS every 8 hours and around medication times. All participants receive IV acetaminophen immediately postpartum and additional pain relief for breakthrough pain as needed. Data Collection: Demographics, delivery details, pain scores, medication use, breastfeeding rates, and satisfaction (using the Birth Satisfaction Scale-BSS-R) will be recorded. Significance: The study aims to fill a gap in the literature on postpartum pain management for vacuum-assisted deliveries, improving care and maternal outcomes.
Trial Details
NCT Number NCT07534969
Lead Sponsor Yael Yagur
Collaborators: Meir Medical Center
Conditions Vacuum-assisted Deliveries
Enrollment 51 participants
Start Date 2024-09-21
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-16