NCT05097950

Labor Induction and Pain Relief With Paracetamol Versus Placebo

Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. An assessment of pain management will be conducted using various assessment tools. additionally, mode of delivery and time from catheter insertion to delivery will be assessed.

Detailed description

Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. assessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10. An assessment of pain management will also be conducted using various assessment tools: 1. Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals. 2. Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter. 3. Patient Experience Questionnaire - upon transfer to delivery room. 4. Socio-demographic Questionnaire Additionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).

Conditions

• Labor Pain

Interventions

Type	Name	Description
DRUG	Administration of 1 gr paracetamol I.V	Administration of 1 gr paracetamol I.V

Timeline

• Start date: 2021-09-02
• Primary completion: 2023-01-09
• Completion: 2023-01-16
• First posted: 2021-10-28
• Last updated: 2025-01-09

Locations

1 site across 1 country: Israel