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
152 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
The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics. The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.
CONDITIONS
Official Title
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cesarean delivery
- Adults 18 years and older
- Term delivery 37 weeks gestation anticipated at time of delivery
- ASA Physical Status 2 or 3
- Able to provide informed consent
- Either not planning to breastfeed or ketamine use indicated for pain management plan
- For control participants: Age 18 years and older
- Control participants can be male or female
- Control participants with ASA Physical Status 1, 2, or 3
- Able to provide informed consent
You will not qualify if you...
- Undergoing general anesthesia for cesarean delivery
- Allergy to ketamine
- ASA Physical Status 4 or higher
- Contraindications to neuraxial anesthesia
- Preterm delivery (less than 37 weeks gestation)
- Anticipated fetal-neonatal complex care plan
- History of ketamine or PCP abuse
- History of schizophrenia or psychosis
- History of liver or renal insufficiency
- History of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine
- Participating in another pain or depression intervention trial
- Undergoing hormonal or gender affirming therapies
- Pre-eclampsia with severe features
- Hemodynamic instability
- Unable to participate in study procedures
- Use of contraindicated medications including oral antihypertensives (except for hypertensive disorders of pregnancy), intravenous magnesium (except for pre-eclampsia with severe features), ketamine, phencyclidine, psilocybins, psychedelics, lithium, valproate, carbamazepine, lamotrigine, haloperidol, chlorpromazine, fluphenazine, aripiprazole, clozapine, or other typical or atypical antipsychotics
- Pregnant or pregnant within the last 6 weeks (for control participants)
- Unwilling to provide urine sample for pregnancy testing (female controls)
AI-Screening
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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
CONTACT
A
Alexandra Anderson, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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