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Vaginal Postpartum Pain Management Protocol Comparison

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ClinicalTrials.gov Identifier: NCT04087317
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gal Bachar MD, Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Pain Post Partum Depression Opioid Use Breast Feeding Drug: Paracetamol 500 Mg Oral Tablet Drug: Ibuprofen 400Mg Tab Drug: Ibuprofen 400 mg Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fixed time interval group.
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.
Drug: Paracetamol 500 Mg Oral Tablet
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
Other Name: Acetaminophen

Drug: Ibuprofen 400Mg Tab
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.

Experimental: 'On-demand' group.
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.
Drug: Paracetamol 500 Mg Oral Tablet
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
Other Name: Acetaminophen

Drug: Ibuprofen 400 mg
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.




Primary Outcome Measures :
  1. Visual analog scale (VAS) score difference. [ Time Frame: Up to 48 hours postpartum. ]
    Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).


Secondary Outcome Measures :
  1. Amount of additional analgesia requirements. [ Time Frame: Up to 48 hours postpartum. ]
    Total amount of additional analgesia 48 hours following a vaginal delivery.

  2. Total analgesia requirements. [ Time Frame: Up to 48 hours postpartum. ]
    Total amount of analgesics use during 48 hours following a vaginal delivery.

  3. Breastfeeding rate. [ Time Frame: Up to 48 hours postpartum. ]
    The rate of women who breastfeed their newborns and breastfeeding frequency.

  4. Treatments side effects. [ Time Frame: Up to 48 hours postpartum. ]
    Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087317


Contacts
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Contact: Gal Bachar, MD +972-524-858699 gal.bachar13@gmail.com

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Gal Bachar, MD Rambam Medical Health Center

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Responsible Party: Gal Bachar MD, Principal investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04087317     History of Changes
Other Study ID Numbers: Rambam Health Care Center.
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action