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NCT04037085 · ClinicalTrials.gov registry record · Phase 2
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
A Phase 2 study, sponsored by Grace Lim, MD, MS.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04037085: Completed Phase 2 study, sponsored by Grace Lim, MD, MS.
NCT04037085 is a Phase 2 study that has completed, run by Grace Lim, MD, MS. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04037085, a Phase 2 study, has completed, sponsored by Grace Lim, MD, MS.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk transfer of ketamine and its metabolites will be assessed. Additionally calculated estimations for neonatal and infant exposure will be assessed. In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include postpartum pain, depression scores, central sensitization measures, patient-reported postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute post-cesarean period and up to 12 weeks postpartum in a randomized controlled trial.
Primary Outcome
Plasma will be used to calculate area under the plasma concentration-time curve (AUC 0-∞) of ketamine levels during infusion. The area under the plasma drug concentration-time curve (AUC) reflects the actual body exposure to drug after administration of a dose of the drug.
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-08-01 |
| Phase | Phase 2 |
What the finished NCT04037085 record still lists
NCT04037085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT04037085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04037085 about?
NCT04037085 is a clinical study titled "Ketamine to Improve Recovery After Cesarean Delivery - Part 1". The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical...
What is the current status of trial NCT04037085?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2019-10-09. Estimated completion is 2021-08-01.
What interventions are being tested in trial NCT04037085?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT04037085?
This trial is sponsored by Grace Lim, MD, MS, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04037085's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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