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Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression

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ClinicalTrials.gov Identifier: NCT03336541
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : December 13, 2021
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE November 8, 2017
Last Update Posted Date December 13, 2021
Actual Study Start Date  ICMJE November 23, 2017
Actual Primary Completion Date May 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
The score of postpartum depression at 48 hous after childbirth. [ Time Frame: At 48 hours after delivery. ]
Postpartum depression is assessed with Edinburgh postnatal depression scale (EPDS) at 48 hours after childbirth. The EPDS is a 10-item self-rating post-natal depression scale. Each item is scored from 0 to 3, resulting an overall score ranging from 0-30; a high score indicates severe depression.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
The incidence of postpartum depression at 42 days after childbirth. [ Time Frame: At 42 days after delivery. ]
Postpartum depression is assessed with Edinburgh postnatal depression scale (EPDS) at 42 days after childbirth.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • Time of first breast feeding. [ Time Frame: From delivery to 24 hours after delivery. ]
    Time of first breast feeding.
  • The proportion of neonates with breast feeding. [ Time Frame: At 24 hours after delivery. ]
    The proportion of neonates with breast feeding.
  • Duration of neonatal sleep within 24 hours after delivery. [ Time Frame: During the first 24 hours after delivery. ]
    Duration of neonatal sleep within 24 hours after delivery.
  • Length of stay in hospital after delivery. [ Time Frame: From childbirth up to 30 days after delivery. ]
    Length of stay in hospital after delivery.
  • The score of postpartum depression at 42 days after delivery. [ Time Frame: At 42 days after delivery. ]
    Postpartum depression is assessed with EPDS at 42 days after childbirth.
  • Incidence of postpartum depression at 42 days after delivery. [ Time Frame: At 42 days after delivery. ]
    Postpartum depression is assessed with EPDS at 42 days after childbirth. A EPDS score of 10 or above is defined as postpartum depression.
  • Incidence of maternal complications with 42 days after delivery. [ Time Frame: From childbirth up to 42 days after delivery. ]
    Incidence of maternal complications with 42 days after delivery.
  • Incidence of neonatal complications with 42 days after delivery. [ Time Frame: From childbirth up to 42 days after delivery. ]
    Incidence of neonatal complications with 42 days after delivery.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • Time of first breast feeding. [ Time Frame: From delivery to 24 hours after delivery. ]
    Time of first breast feeding.
  • The proportion of neonates with breast feeding. [ Time Frame: At 24 hours after delivery. ]
    The proportion of neonates with breast feeding.
  • Duration of neonatal sleep within 24 hours after delivery. [ Time Frame: During the first 24 hours after delivery. ]
    Duration of neonatal sleep within 24 hours after delivery.
  • Maternal depression score. [ Time Frame: At 48 hours after delivery. ]
    Maternal depression scor assessed with EPDS at 48 hours after delivery.
  • Length of stay in hospital after delivery. [ Time Frame: From childbirth up to 30 days after delivery. ]
    Length of stay in hospital after delivery.
  • Incidence of maternal complications with 42 days after delivery. [ Time Frame: From childbirth up to 42 days after delivery. ]
    Incidence of maternal complications with 42 days after delivery.
  • Incidence of neonatal complications with 42 days after delivery. [ Time Frame: From childbirth up to 42 days after delivery. ]
    Incidence of neonatal complications with 42 days after delivery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression
Official Title  ICMJE Effects of Intraoperative Low-dose Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression Undergoing Cesarean Delivery: Blind Test, Randomized, Placebo-controlled Trial
Brief Summary Postpartum depression is common in mothers early after childbirth and produces harmful effects not only on mothers, but also on infants and young children. Parturients with prenatal depression are at increased of postpartum depression. Low-dose ketamine can be used for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. This study is designed to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.
Detailed Description

Postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 15% to 20%. The development of postpartum depression produces harmful effects not only on mothers, but also on infants and young children. Prenatal depression or high depression score is an independent risk factor for the development of postpartum depression.

Ketamine is commonly used as an general anesthetic. In addition, low-dose ketamine is recommended for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. However, evidences in this aspect are insufficient. The purpose of this study is to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Perinatal Depression
  • Ketamine
  • Cesarean Delivery
  • Postpartum Depression
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
    Other Name: Ketamine hydrochloride
  • Drug: Placebo
    Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: Ketamine group
    Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo group
    Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
    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 Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2018)
64
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
60
Actual Study Completion Date  ICMJE June 25, 2018
Actual Primary Completion Date May 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parturients with age from 18 to 45 years and scheduled for elective cesarean delivery;
  • Prenatal depression score (EPDS) of 10 or higher;
  • Provide written informed consents.

Exclusion Criteria:

  • Refused to participate in the study;
  • History of schizophrenia or other disease that prevent normal communication before delivery;
  • Presence of contraindications to neuraxial anesthesia, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as spinal canal tumor, lumbar disc prolapse, history of spinal trauma), systemic infection (such as sepsis, bacteremia), local infection in the site of puncture, or coagulopathy;
  • Severe complications during pregnancy (such as severe preeclampsia, placenta accreta, HELLP syndrome);
  • Severe comorbidity before pregnancy (such as severe cardiac dysfunction);
  • Scheduled to undergo cesarean delivery under general anesthesia;
  • Other reasons that are considered unsuitable for study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03336541
Other Study ID Numbers  ICMJE 2017[36]
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dong-Xin Wang, Peking University First Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Peking University First Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date December 2021

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