Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine to Prevent PPD After Cesarean (PoCKet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227704
Recruitment Status : Not yet recruiting
First Posted : January 14, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Drug: Ketamine 50 MG/ML Drug: Control Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised to one of three groups (two interventional and one control).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The ketamine and placebo study injectates (subcutaneous and intravenous) will be prepared, in way that does not allow differentiation, by pharmacy staff who are otherwise uninvolved in the study. Participants will be allocated to groups using a random sequence generator. The patients, investigators and outcome assessors will remain unaware of their group until data collection is complete for all participants.
Primary Purpose: Prevention
Official Title: Postpartum Depression After Cesarean Delivery: Ketamine as a Preventative Intervention: A Feasibility Pilot-study
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Control
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
Drug: Control
Administration of 0.9% Sodium Chloride (N/S)

Experimental: Ketamine SC
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
Drug: Ketamine 50 MG/ML
Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).

Drug: Control
Administration of 0.9% Sodium Chloride (N/S)

Experimental: Ketamine IVI
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Drug: Ketamine 50 MG/ML
Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).

Drug: Control
Administration of 0.9% Sodium Chloride (N/S)




Primary Outcome Measures :
  1. The incidence of PPD, as defined as EPDS greater than 10 out of 30 [ Time Frame: 42 days postpartum ]
    Establish a sufficient burden of disease (>10%) in our population to warrant a full RCT

  2. Percentage of eligible patients consenting to participation [ Time Frame: Through study completion, an average of 1 year ]
    Establish a recruitment rate of greater than 50% to confirm the feasibility of conducting an RCT in our population

  3. Percentage of patients with a complete dataset [ Time Frame: Through study completion, an average of 1 year ]
    Ensure that the design of assessments and data collection make it possible to achieve a complete dataset in >90% of participants

  4. Number of patients in study arms experiencing one or more severe side effects [ Time Frame: Through study completion, an average of 1 year ]
    Ascertain that neither of the chosen routes of administration of ketamine are intolerable to patients, as defined as the incidence of one or more severe side effects experienced by >10% of participants in that study arm.


Secondary Outcome Measures :
  1. Dose of opiate analgesics administered [ Time Frame: Intraoperative phase ]
    Intraoperative supplementary analgesia in morphine milligram equivalents

  2. Dose of ketorolac administered [ Time Frame: Intraoperative phase ]
    Intraoperative supplementary analgesia

  3. Incidence of intraoperative hypotension of a systolic BP of less than 90 [ Time Frame: Intraoperative phase ]
    Incidence of systolic BP less than 90 mmHg

  4. Maximum intraoperative pain (NRS) [ Time Frame: Intraoperative phase ]
    Reported maximal level of intraoperative pain on the numerical rating scale 0 - 10

  5. Adverse effects [ Time Frame: Intraoperative and 2 and 6 hours postoperatively ]
    Incidence and severity (mild, moderate or severe) of nausea, vomiting, pruritus, dizziness, sedation, shivering, anxiety, euphoria, hallucinations, amnesia, blurred vision, diplopia, nystagmus

  6. Plasma concentrations of ketamine [ Time Frame: At baseline and approximately 20, 40 and 100 minutes postpartum ]
    Assays of venous blood samples

  7. Total opiate consumption in morphine equivalents [ Time Frame: In the first 2 days postpartum ]
    Morphine equivalents

  8. Surgical site pain: numerical rating scale (NRS 0-10) [ Time Frame: At 2, 6, 24 and 48 hours after delivery and on postpartum days 21 and 42 ]
    On a numerical rating scale (NRS 0-10)

  9. Edinburgh Postpartum Depression Scale (0 - 30, a higher score represents greater depressive symptomatology) [ Time Frame: On postpartum days 1, 2, 21 and 42 ]
    Validated measure of depressive symptoms in the postpartum period

  10. Apgar scores [ Time Frame: At 1 and 5 minutes after delivery ]
    Score out of 10, of neonatal status

  11. Admission to NICU [ Time Frame: Postpartum day 1 ]
    Incidence of admission

  12. Breastfeeding success [ Time Frame: Postpartum days 1 and 2 ]
    Yes or no

  13. Incidence of intraoperative hypertension of a systolic BP greater than 140 mmHg [ Time Frame: Intraoperative phase ]
    Systolic hypertension of greater than 140 mmHg

  14. Incidence of intraoperative bradycardia of less than 40 bpm [ Time Frame: Intraoperative phase ]
    Bradycardia less than 40 bpm

  15. Incidence of intraoperative tachycardia of greater than 110 bpm [ Time Frame: Intraoperative phase ]
    Tachycardia greater than 110 bpm

  16. Incidence of Anxiety on the Generalized Anxiety Disorder- 7 item scaleGAD-7 [ Time Frame: On day of surgery, and postpartum days 1, 2, 21 and 42 ]
    Validated scale for anxiety. Score out of 21.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227704


Contacts
Layout table for location contacts
Contact: Ben Swan 314-273-8257 bswan@wustl.edu
Contact: Kristi Kraus, RN 314-273-7921 kristinkraus@wustl.edu

Locations
Layout table for location information
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Principal Investigator: David T Monks, MBChB FRCA         
Sponsors and Collaborators
Washington University School of Medicine
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04227704    
Other Study ID Numbers: 201910191
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depression
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action