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Completed

NCT Number: NCT04087317

Vaginal Postpartum Pain Management Protocol Comparison

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.

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Key information

Conditions

Pain Behavior Breast Feeding Depression, Postpartum Depressive Disorder Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Post Partum Depression Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam

Ramat Yishai, 3009500, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Paracetamol 1000 Mg Oral Tablet

Drug

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 names: Acetaminophen

Ibuprofen 400Mg Tab

Drug

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

Ibuprofen 400 mg

Drug

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

MIR

Drug

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).

Primary outcomes

  1. Visual analog scale (VAS) score difference in the 24 first hours.

    Time frame: In the first 24 hours postpartum.

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

Secondary outcomes

  1. Amount of additional analgesia requirements.

    Time frame: Up to maternal discharge (5 days)

    Total amount of additional analgesia up to maternal discharge.

  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.

  5. Visual analog scale (VAS) score difference up to maternal discharge.

    Time frame: 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). up to 5 days.

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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 12, 2019
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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