Actively Recruiting
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Led by Grace Lim, MD, MS · Updated on 2026-03-25
50
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
Sponsors
G
Grace Lim, MD, MS
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how ketamine is processed and acts in the body after childbirth, specifically following cesarean delivery. The goal is to better understand ketamine's movement and effects in postpartum women, and to compare these findings with non-pregnant women and men to explore sex differences in ketamine metabolism. This study addresses important gaps in knowledge about pain management and postpartum depression treatment in women after cesarean delivery. Participants who have undergone cesarean delivery will receive a ketamine infusion starting after the baby is delivered, with a loading dose given over one hour followed by a maintenance dose over 11 hours. A control group of healthy men and non-pregnant women will receive the same infusion schedule. Both groups will be closely monitored to compare ketamine pharmacokinetics and pharmacodynamics. During the study, participants will have blood samples taken to measure ketamine levels over 24 hours. Researchers will track pain levels and depression symptoms up to 12 weeks after infusion. Side effects and patient acceptance of the treatment will also be recorded. The study aims to gather detailed data on ketamine's effects and metabolism in postpartum and control subjects, with the entire participation lasting up to 12 weeks for follow-up assessments.
CONDITIONS
Brief Title
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Cesarean delivery planned or recent
- Term delivery of 37 weeks gestation or more expected
- ASA physical status classification 2 or 3
- Able to provide informed consent
- For postpartum group: either not planning to breastfeed or ketamine use planned for pain management
- For control group: male or female, ASA physical status classification 1, 2, or 3
- Able to provide informed consent
You will not qualify if you...
- General anesthesia planned for cesarean delivery
- Allergy to ketamine
- ASA physical status classification 4 or higher
- Contraindications to neuraxial anesthesia
- Preterm delivery under 37 weeks gestation
- Anticipated complex fetal or neonatal care
- History of ketamine or PCP abuse
- History of schizophrenia or psychosis
- History of liver or kidney problems
- History of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other ketamine contraindications
- Participation in another pain or depression trial
- Undergoing hormonal or gender affirming therapies
- Severe pre-eclampsia
- Hemodynamic instability
- Unable to participate in study procedures
- Use of contraindicated medications including certain antihypertensives, magnesium, psychedelics, lithium, antipsychotics, and others
- Pregnant or pregnant within last 6 weeks (for controls)
- Unwilling to provide urine pregnancy test (for female controls)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 hours
Participants receive a ketamine infusion for 12 hours after cesarean delivery or as a healthy control. The infusion includes a loading dose for 1 hour followed by a maintenance dose for 11 hours.
1 treatment visit (in-person)
Duration - Up to 12 weeks
Participants are monitored for pain and depression symptoms up to 12 weeks after the ketamine infusion.
Follow-up visits over 12 weeks
Trial Site Locations
Total: 2 locations
1
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
UPMC Montefiore Clinical and Translational Research Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
A
Amy Monroe, MPH, MBA
A
Alexandra Anderson, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here