Postpartum Depression Clinical Trial
Official title:
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Verified date | September 2023 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
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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