Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- PAIN assessment during catheter balloon insertion
Study Overview
Brief 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:
- 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%).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Nulliparity
Exclusion Criteria
- •Sensitivity to paracetamol.
- •Past Cesarean section
- •Multiple pregnancy
Arms & Interventions
Intervention Group
Administration of 1 gr paracetamol I.V
Intervention: Administration of 1 gr paracetamol I.V (Drug)
Control Group
Administration of 100 ml. sodium chloride 0.9% IV
Intervention: Administration of 1 gr paracetamol I.V (Drug)
Outcomes
Primary Outcomes
PAIN assessment during catheter balloon insertion
Time Frame: through study completion, an average of 1 year
pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10
maternal satisfaction
Time Frame: through study completion, an average of 1 year
maternal satisfaction will be evaluated using a questionnaire
Secondary Outcomes
- need for additional analgesic agent(through study completion, an average of 1 year)
- maternal mobility(through study completion, an average of 1 year)
Investigators
Inshirah Sgayer
inshirah sgayer
Western Galilee Hospital-Nahariya