drugset / Trial / NCT07534969

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

NCT07534969

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-09-21
Primary completion
2026-03-01
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1 g Oral
Comparator Diclofenac Other / unclassified 50 mg Oral

Indications

No indication recorded.