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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.
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:
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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | Administration of 1 gr paracetamol I.V |
|
| Control Group | Placebo Comparator | Administration of 100 ml. sodium chloride 0.9% IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of 1 gr paracetamol I.V | Drug | Administration of 1 gr paracetamol I.V |
|
| 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 | through study completion, an average of 1 year |
| maternal satisfaction | maternal satisfaction will be evaluated using a questionnaire | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| need for additional analgesic agent | need for additional analgesic agent than paracetamol after catheter balloon insertion | 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 |
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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 Nulliparity
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inshirah Sgayer | Nahariya | 2210001 | Israel |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| through study completion, an average of 1 year |