Labor Induction and Pain Relief With Paracetamol Versus Placebo
NCT ID: NCT05097950
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
141 participants
INTERVENTIONAL
2021-09-02
2023-01-16
Brief Summary
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Detailed Description
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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%).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention Group
Administration of 1 gr paracetamol I.V
Administration of 1 gr paracetamol I.V
Administration of 1 gr paracetamol I.V
Control Group
Administration of 100 ml. sodium chloride 0.9% IV
Administration of 1 gr paracetamol I.V
Administration of 1 gr paracetamol I.V
Interventions
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Administration of 1 gr paracetamol I.V
Administration of 1 gr paracetamol I.V
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Past Cesarean section
3. Multiple pregnancy
18 Years
44 Years
FEMALE
No
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Inshirah Sgayer
inshirah sgayer
Locations
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Inshirah Sgayer
Nahariya, , Israel
Countries
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Other Identifiers
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0065-21-NHR
Identifier Type: -
Identifier Source: org_study_id
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