Labor Pain
Conditions
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: 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%).
Interventions
DRUGAdministration of 1 gr paracetamol I.V
Administration of 1 gr paracetamol I.V
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
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
1. Sensitivity to paracetamol. 2. Past Cesarean section 3. Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAIN assessment during catheter balloon insertion | 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 | through study completion, an average of 1 year | maternal satisfaction will be evaluated using a questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| need for additional analgesic agent | through study completion, an average of 1 year | need for additional analgesic agent than paracetamol after catheter balloon insertion |
| maternal mobility | through study completion, an average of 1 year | women were asked through a questionnaire about whether they were immoblile after the catheter insetion using a score from 0 to 10 |
Countries
Israel
Outcome results
None listed