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Low-dose S-ketamine in Women With Prenatal Depression

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ClinicalTrials.gov Identifier: NCT04414943
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : July 12, 2021
Sponsor:
Collaborators:
Peking University International Hospital
Beijing Tiantan Hospital
Hunan Provincial Maternal and Child Health Care Hospital
Nanjing Maternal and Child Health Care Hospital
Huaian Maternal and Child Health Care Hospital
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Tracking Information
First Submitted Date  ICMJE June 1, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date July 12, 2021
Actual Study Start Date  ICMJE June 19, 2020
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
The incidence of depression at 42 days postpartum. [ Time Frame: At 42 days after childbirth. ]
Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • Maternal depression scores at 7 and 42 days postpartum. [ Time Frame: At 7 and 42 days after childbirth. ]
    Maternal depression will be assessed with the Edinburgh postnatal depression scale (EPDS). The assessment will be conducted by a telephone interview or a face-to-face interview.
  • Intensity of pain at 1, 7, and 42 days postpartum. [ Time Frame: At 1, 7, and 42 days after childbirth. ]
    Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
  • Maternal breast feeding at 1, 7, and 42 days postpartum. [ Time Frame: At 1, 7, and 42 days after childbirth. ]
    The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
  • Length of hospital stay after giving birth. [ Time Frame: Up to 30 days after giving birth. ]
    Length of hospital stay after giving birth.
  • Incidence of maternal complications within 42 days postpartum. [ Time Frame: Up to 42 days after giving birth. ]
    Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
  • Incidence of neonatal diseases within 42 days. [ Time Frame: Up to 42 days after birth. ]
    Neonatal diseases are defined as those that require medical intervention.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
  • Maternal depression scores at 7 and 42 days postpartum. [ Time Frame: At 7 and 42 days after childbirth. ]
    Maternal depression will be assessed with the Edinburgh postnatal depression scale (EPDS). The assessment will be conducted by a telephone interview or a face-to-face interview.
  • Intensity of pain at 1, 7, and 42 days postpartum. [ Time Frame: At 1, 7, and 42 days after childbirth. ]
    Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
  • Maternal breast feeding at 1, 7, and 42 days postpartum. [ Time Frame: At 1, 7, and 42 days after childbirth. ]
    The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
  • Length of hospital stay after giving birth. [ Time Frame: Up to 30 days after giving birth. ]
    Length of hospital stay after giving birth.
  • Maternal complications within 42 days postpartum. [ Time Frame: Up to 42 days after giving birth. ]
    Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
  • Neonatal disease with 42 days. [ Time Frame: Up to 42 days after birth. ]
    Neonatal disease are defined as those that require medical intervention.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose S-ketamine in Women With Prenatal Depression
Official Title  ICMJE Effects of Low-dose S-ketamine on the Incidence of Postpartum Depression in Women With Prenatal Depression: a Randomized, Double-blind, Placebo-controlled Trial
Brief Summary Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.
Detailed Description Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Prenatal Depression
  • Ketamine
  • Postpartum Depression
Intervention  ICMJE
  • Drug: S-ketamine
    For women in this group, active drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
    Other Name: S-ketamine hydrochloride
  • Drug: Placebo
    For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: S-katamine group
    For women in this group, study drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.
    Intervention: Drug: S-ketamine
  • Placebo Comparator: Placebo group
    For women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2020)
364
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Maternal age ≥18 years;
  2. Prenatal Edinburgh postnatal depression scale score ≥10 points.

Exclusion Criteria:

  1. A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
  2. Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
  3. American Society of Anesthesiologists classification ≥III;
  4. Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: This clinical trail is based in pregnant women.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dong-Xin Wang, MD,PHD 8610 83572784 wangdongxin@hotmail.com
Contact: Yuan Zeng, MD 8610 83572460 yuan_zeng@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04414943
Other Study ID Numbers  ICMJE 2019[336]
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will be available by contacting Dr. Dong-Xin Wang (wangdongxin@hotmail.com) after the trial is completed.
Responsible Party Dong-Xin Wang, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE
  • Peking University International Hospital
  • Beijing Tiantan Hospital
  • Hunan Provincial Maternal and Child Health Care Hospital
  • Nanjing Maternal and Child Health Care Hospital
  • Huaian Maternal and Child Health Care Hospital
Investigators  ICMJE
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP