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Clinical Trial 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.


Clinical Trial 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%). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05097950
Study type Interventional
Source Western Galilee Hospital-Nahariya
Contact
Status Not yet recruiting
Phase N/A
Start date November 2021
Completion date December 2022

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