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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
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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:

  1. Sensitivity to paracetamol.
  2. Past Cesarean section
  3. 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

    First Posted
    September 12, 2021
    Last Updated
    October 17, 2021
    Sponsor
    Western Galilee Hospital-Nahariya
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    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

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    Labor Induction and Pain Relief With Paracetamol Versus Placebo

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