Labor Induction and Pain Relief With Paracetamol Versus Placebo
Primary Purpose
Labor Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Administration of 1 gr paracetamol I.V
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Administration of 1 gr paracetamol I.V
Administration of 100 ml. sodium chloride 0.9% IV
Outcomes
Primary Outcome Measures
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
vaginal delivery rate
vaginal delivery rate in percents (%) will be assessed and compared in the two groups Rate of cesarean sections will be assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT05097950
First Posted
September 12, 2021
Last Updated
October 17, 2021
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT05097950
Brief Title
Labor Induction and Pain Relief With Paracetamol Versus Placebo
Official Title
Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Administration of 1 gr paracetamol I.V
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Administration of 100 ml. sodium chloride 0.9% IV
Intervention Type
Drug
Intervention Name(s)
Administration of 1 gr paracetamol I.V
Intervention Description
Administration of 1 gr paracetamol I.V
Primary Outcome Measure Information:
Title
PAIN assessment during catheter balloon insertion
Description
pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10
Time Frame
One year
Title
vaginal delivery rate
Description
vaginal delivery rate in percents (%) will be assessed and compared in the two groups Rate of cesarean sections will be assessed
Time Frame
one year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Labor Induction and Pain Relief With Paracetamol Versus Placebo
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