Labor Induction and Pain Relief With Paracetamol Versus Placebo

Study Overview
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Brief Summary
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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
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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: Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals. Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter. Patient Experience Questionnaire - upon transfer to delivery room. 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%).

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

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Administration of 1 gr paracetamol I.V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Exclusion Criteria: Sensitivity to paracetamol. Past Cesarean section Multiple pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>Administration of 1 gr paracetamol I.V | Drug: Administration of 1 gr paracetamol I.V<br>* Administration of 1 gr paracetamol I.V<br>|
| Placebo Comparator: Control Group<br>Administration of 100 ml. sodium chloride 0.9% IV | Drug: Administration of 1 gr paracetamol I.V<br>* Administration of 1 gr paracetamol I.V<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One year | 
| vaginal delivery rate | vaginal delivery rate in percents (%) will be assessed and compared in the two groups Rate of cesarean sections will be assessed | one year |