Stopped: PI is leaving the university
The goal of this open label case series is to learn about the feasibility of conducting a future randomised controlled trial to evaluate how well the Perinatal SMILES intervention works in improving post-cesarean mood in low-income women. The main questions it aims to answer are: 1. Is it feasible to recruit a sufficient number of participants? 2. Is it feasible to administer Perinatal SMILES and 3. Is it feasible to collect participant outcomes? To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine Participants will: 1. Complete five sessions of interpersonal therapy 2. Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day 3. Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection 4. Undergo assessments of brain electrical activity (at rest and evoked by trans-cranial magnetic stimulation) before and at three timepoints in the 10 hours after each ketamine injection 5. Complete mood assessments over the first 12 postpartum weeks
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Depressive symptoms
Timeframe: through postoperative day 84
P30 (TMS-evoked potential)
Timeframe: 4 days
N45 (TMS-evoked potential)
Timeframe: 4 days
P60 (TMS-evoked potential)
Timeframe: 4 days
N100 (TMS-evoked potential)
Timeframe: 4 days
Cortical evoked activity (CEA)
Timeframe: 4 days
Anxiety
Timeframe: through postoperative day 84
Psychosocial stress
Timeframe: at enrollment 1 day
Post-Traumatic Stress Disorder (PTSD)
Timeframe: through postoperative day 84
Obstetric Quality of Recovery
Timeframe: through postoperative day 84
Number of participants who successfully breastfeed their newborn baby
Timeframe: 4 days
Adverse effects - sedation
Timeframe: 4 days
Adverse effects - Blurred vision
Timeframe: 4 days
Adverse effects - diplopia
Timeframe: 4 days
Adverse effects - dizziness
Timeframe: 4 days
Adverse effects - euphoria
Timeframe: 4 days
Adverse effects - amnesia
Timeframe: 4 days
Adverse effects - hallucinations
Timeframe: 4 days
Adverse effects - nystamus
Timeframe: 4 days
Antidepressant treatment
Timeframe: through postoperative day 84