NCT04017442

Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postpartum Pain
• Postpartum Depression
• Opioid Consumption

Interventions

Type	Name	Description
DRUG	Preservative Free Morphine	After delivery of the baby patients will receive via the epidural catheter prior to its removal.
DRUG	Saline	After delivery of the baby patients will receive via the epidural catheter prior to its removal.

Timeline

• Start date: 2019-10-19
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2019-07-12
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study