Phase 3
N=25
Ketamine to Prevent PPD After Cesarean
Postpartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT04227704 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30 — 4; 2; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketamine 50 MG/ML (Drug); Control (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30 |
4; 2; 5 | — |
| PRIMARY Percentage of Eligible Patients Consenting to Participation |
7; 8; 8 | — |
| PRIMARY Percentage of Patients With a Complete Dataset |
3; 4; 7 | — |
| PRIMARY Number of Patients in Study Arms Experiencing One or More Severe Side Effects |
0; 0; 0 | — |
| SECONDARY Dose of Opiate Analgesics Administered |
88.6; 68.4; 67.0 | — |
| SECONDARY Dose of Ketorolac Administered (mg) |
30; 30; 30 | — |
| SECONDARY Prevalence of Intraoperative Hypotension |
1; 2; 1 | — |
| SECONDARY Maximum Intraoperative Pain (NRS) |
3; 5; 1.5 | — |
| SECONDARY Adverse Effects |
0; 2; 1; 2; 0; 3 | — |
| SECONDARY Plasma Concentrations of Ketamine |
— | — |
| SECONDARY Total Opiate Consumption in Morphine Equivalents |
88.6; 68.4; 67 | — |
| SECONDARY Surgical Site Pain: Numerical Rating Scale (NRS 0-10) |
2.86; 2.1428571428571; 2.5; 3; 4.714285714; 1.875 | 0.09 |
| SECONDARY Edinburgh Postpartum Depression Scale (EPDS) |
7.5; 4.75; 4.25; 8.43; 5.63; 5.38 | 0.08 |
| SECONDARY Apgar Scores |
8; 8; 8; 9; 9; 9 | — |
| SECONDARY Admission to NICU |
3; 1; 3 | — |
| SECONDARY The Number of Participants Achieving Breastfeeding Success |
3; 6; 5; 3; 6; 5 | — |
| SECONDARY Prevalence of Intraoperative Hypertension |
1; 0; 1 | — |
| SECONDARY Prevalence of Intraoperative Bradycardia |
0; 0; 2 | — |
| SECONDARY Prevalence of Intraoperative Tachycardia |
0; 1; 1 | — |
| SECONDARY Postpartum Anxiety |
5.17; 5.63; 3.5; 6; 4.75; 4.5 | 0.44 |
Summary
The investigators plan to randomise participants to receive ketamine or placebo control subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to assess the incidence of postpartum depression. This feasibility pilot study is designed to explore the adequacy of the study procedures and tolerability of the interventions.
Eligibility Criteria
Inclusion criteria
- Term pregnancy
- Age 18-45 years of age
- Scheduled cesarean delivery under neuraxial anesthesia
Exclusion criteria
- ASA classification IV or V
- History of psychotic episodes
- History of allergy to ketamine
- Inability to communicate in English or any other barrier to providing informed consent
Data sourced from ClinicalTrials.gov (NCT04227704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.