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Fixed-Interval vs. On-Demand Analgesia After Vacuum-Assisted Delivery: RCT
Sponsor: Yael Yagur
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.
Official title: Fixed-time Interval vs. On-demand Analgesia Following Vacuum-assisted Vaginal Delivery: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2024-09-21
Completion Date
2026-03-01
Last Updated
2026-04-16
Healthy Volunteers
No
Conditions
Interventions
Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.
Oral acetaminophen (1 g) and diclofenac (50 mg) administered during the first 24 hours postpartum together every 8 houers
On demand analgesia
Administration of analgesics upon patient request
Locations (1)
Meir Medical Center
Kfar Saba, Israel