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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Opioid Consumption
• Postpartum Depression
• Postpartum Pain

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