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Vaginal Postpartum Pain Management Protocol Comparison

NCT04087317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-03

No results posted yet for this study

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.

Conditions

  • Pain
  • Post Partum Depression
  • Opioid Use
  • Breast Feeding

Interventions

DRUG

Paracetamol 1000 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.

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.

DRUG

Paracetamol 1000 Mg Oral Tablet

The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.

DRUG

Ibuprofen 400 mg

The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.

DRUG

MIR

At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Gal Bachar, MD · Rambam Medical Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-06-30
Completion
2022-07-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04087317 on ClinicalTrials.gov