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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
141
Administration of 1 gr paracetamol I.V
Inshirah Sgayer
Nahariya, Israel
PAIN assessment during catheter balloon insertion
pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10
Time frame: through study completion, an average of 1 year
maternal satisfaction
maternal satisfaction will be evaluated using a questionnaire
Time frame: through study completion, an average of 1 year
need for additional analgesic agent
need for additional analgesic agent than paracetamol after catheter balloon insertion
Time frame: through study completion, an average of 1 year
maternal mobility
women were asked through a questionnaire about whether they were immoblile after the catheter insetion using a score from 0 to 10
Time frame: through study completion, an average of 1 year
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