Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Phase 4

Completed

• Conditions: Postpartum Pain; Postpartum Depression; Opioid Consumption
• Interventions: Drug: Preservative Free Morphine; Drug: Saline

• Registration Number: NCT04017442
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2019-10-19
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-07
• Results First Submitted: 2024-07-23
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Pregnant women in labor

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Preservative Free Morphine	2mg preservative free morphine
Saline	Saline	4 mL preservative free saline

Primary Outcome Measures

Name	Time	Method
Opioid Consumption in MME	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 Outcome Measures

Name	Time	Method
Obstetric Quality of Recovery Score (OBSQ10)	24 hours	OBSQ10 total score 0-100, with higher score indicating better health status
Pain Score	at 24 hours	Pain Score: Likert full scale 0-10, with higher score indicating more pain
Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10	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.
Number of Participants With Exclusive Breast Feeding	1 week	Participants will respond yes/no as to their breast feeding success and continuation exclusively.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States