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NCT04017442 Clinical Trial

Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Postpartum Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04017442
Other study ID # GCO 18-2789
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 19, 2019
Est. completion date August 31, 2023

Study information
Verified date September 2023
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant women in labor Exclusion Criteria: - Not a candidate for neuraxial anesthesia - Patient refusal - Allergy to morphine - Patients with chronic pain syndromes

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Preservative Free Morphine
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
• Saline
After delivery of the baby patients will receive via the epidural catheter prior to its removal.

Locations
Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Opioid Consumption Quantity of opioid used in 24 hours 24 hours
Secondary Pain Score Pain Score: Likert full scale 1-10, with higher score indicating more pain up to 24 hours
Secondary Obstetric Quality of Recovery Score (OBSQ10) OBSQ10 total score 0-100, with higher score indicating better health status 24 hours
Secondary Edinburgh Postnatal Depression Scale (EPDS) 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. up to 6 weeks
Secondary Number of participants with breast feeding success Participants will respond yes/no as to their breast feeding success and continuation 1 week
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