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Vaginal Postpartum Pain Management Protocol Comparison

Primary Purpose

Pain, Post Partum Depression, Opioid Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Paracetamol 500 Mg Oral Tablet
Ibuprofen 400Mg Tab
Paracetamol 500 Mg Oral Tablet
Ibuprofen 400 mg
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1. Women following term vaginal delivery.

Exclusion Criteria:

  1. Under Age 18 years or older than 45 years.
  2. Women with chronic pain syndrome.
  3. Women with relative or absolute contraindications for paracetamol or NSAIDs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Fixed time interval group.

    'On-demand' group.

    Arm Description

    Once the patient will arrive at the maternity ward the patient will receive paracetamol 1 gram and a tablet of ibuprofen 400 mg. Six hours after patient arrival and every 6 hours the patient will receive a tablet of paracetamol 500 mg and a tablet of ibuprofen 400 mg.

    Patients allocated to this group will receive the same medications in the same combinations and order as described in the 'fixed time interval' group protocol, patients in this group will receive pain treatment only following demand, and the time intervals described above will be considered as the minimal time for giving the next combination of drugs.

    Outcomes

    Primary Outcome Measures

    Visual analog scale (VAS) score difference.
    Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).

    Secondary Outcome Measures

    Amount of additional analgesia requirements.
    Total amount of additional analgesia 48 hours following a vaginal delivery.
    Total analgesia requirements.
    Total amount of analgesics use during 48 hours following a vaginal delivery.
    Breastfeeding rate.
    The rate of women who breastfeed their newborns and breastfeeding frequency.
    Treatments side effects.
    Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.

    Full Information

    First Posted
    August 7, 2019
    Last Updated
    September 11, 2019
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04087317
    Brief Title
    Vaginal Postpartum Pain Management Protocol Comparison
    Official Title
    Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    September 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
    Detailed Description
    More than two million women deliver vaginally every year in the United States (US). Along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement. A stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. The first step includes non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine). In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Post Partum Depression, Opioid Use, Breast Feeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Women following a vaginal delivery, with no exclusion criteria to participate in the study, will be addressed. After receiving all the information about the study, women who choose to participate will be consented. All participants will be randomized to either scheduled analgesic administration (study group) or analgesic administration per women's request (control group) as accustomed at the investigator's unit.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    220 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fixed time interval group.
    Arm Type
    Experimental
    Arm Description
    Once the patient will arrive at the maternity ward the patient will receive paracetamol 1 gram and a tablet of ibuprofen 400 mg. Six hours after patient arrival and every 6 hours the patient will receive a tablet of paracetamol 500 mg and a tablet of ibuprofen 400 mg.
    Arm Title
    'On-demand' group.
    Arm Type
    Experimental
    Arm Description
    Patients allocated to this group will receive the same medications in the same combinations and order as described in the 'fixed time interval' group protocol, patients in this group will receive pain treatment only following demand, and the time intervals described above will be considered as the minimal time for giving the next combination of drugs.
    Intervention Type
    Drug
    Intervention Name(s)
    Paracetamol 500 Mg Oral Tablet
    Other Intervention Name(s)
    Acetaminophen
    Intervention Description
    The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen 400Mg Tab
    Intervention Description
    The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
    Intervention Type
    Drug
    Intervention Name(s)
    Paracetamol 500 Mg Oral Tablet
    Other Intervention Name(s)
    Acetaminophen
    Intervention Description
    The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen 400 mg
    Intervention Description
    The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
    Primary Outcome Measure Information:
    Title
    Visual analog scale (VAS) score difference.
    Description
    Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).
    Time Frame
    Up to 48 hours postpartum.
    Secondary Outcome Measure Information:
    Title
    Amount of additional analgesia requirements.
    Description
    Total amount of additional analgesia 48 hours following a vaginal delivery.
    Time Frame
    Up to 48 hours postpartum.
    Title
    Total analgesia requirements.
    Description
    Total amount of analgesics use during 48 hours following a vaginal delivery.
    Time Frame
    Up to 48 hours postpartum.
    Title
    Breastfeeding rate.
    Description
    The rate of women who breastfeed their newborns and breastfeeding frequency.
    Time Frame
    Up to 48 hours postpartum.
    Title
    Treatments side effects.
    Description
    Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.
    Time Frame
    Up to 48 hours postpartum.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Women following term vaginal delivery. Exclusion Criteria: Under Age 18 years or older than 45 years. Women with chronic pain syndrome. Women with relative or absolute contraindications for paracetamol or NSAIDs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gal Bachar, MD
    Phone
    +972-524-858699
    Email
    gal.bachar13@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gal Bachar, MD
    Organizational Affiliation
    Rambam Medical Health Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33078388
    Citation
    Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
    Results Reference
    derived

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    Vaginal Postpartum Pain Management Protocol Comparison

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