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Completed

NCT Number: NCT04017442

Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.

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Key information

Conditions

Postpartum Pain Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Opioid Consumption Postpartum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Hospital

New York, 10029, United States

About this study

After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo. Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. The study will end at the 6 week postpartum visit with the patient's obstetrician.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women in labor

Exclusion criteria

  • Not a candidate for neuraxial anesthesia
  • Patient refusal
  • Allergy to morphine
  • Patients with chronic pain syndromes

Treatment and study plan

Preservative Free Morphine

Drug

After delivery of the baby patients will receive via the epidural catheter prior to its removal.

Saline

Drug

After delivery of the baby patients will receive via the epidural catheter prior to its removal.

Other names: Placebo

Primary outcomes

  1. Opioid Consumption in MME

    Time frame: within 24 hours of delivery

    Quantity of opioid in morphine milligram equivalents (MME) used within 24 hours of delivery.

    The conversions from opioids to MME were as follows: 2 mg oral hydromorphone as 8 MME, 5 mg oxycodone 7.5 MME. To convert the PO hydromorphone to MME, IV hydromorphone was converted to morphine with a 4:1 ratio to convert to morphine followed by a 1:3 ratio to convert IV to PO.

Secondary outcomes

  1. Pain Score

    Time frame: at 24 hours

    Pain Score: Likert full scale 0-10, with higher score indicating more pain

  2. Obstetric Quality of Recovery Score (OBSQ10)

    Time frame: 24 hours

    OBSQ10 total score 0-100, with higher score indicating better health status

  3. Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10

    Time frame: up to 6 weeks

    Number of Participants with positive EPDS screen in the 6-week post-delivery EPDS defined as a score higher than 10.

    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item instrument to assess postpartum depression, with total score from 0-30. Higher score indicates more depressed symptoms.

  4. Number of Participants With Exclusive Breast Feeding

    Time frame: 1 week

    Participants will respond yes/no as to their breast feeding success and continuation exclusively.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2019
Registry last updated
Aug 14, 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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