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Trial record 66 of 256 for:    postpartum | "Depression"

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 : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Perinatal Depression Ketamine Cesarean Delivery Postpartum Depression Drug: Ketamine Drug: Placebo Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : May 14, 2018
Actual Study Completion Date : June 25, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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.
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

Placebo Comparator: Placebo group
Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time of first breast feeding. [ Time Frame: From delivery to 24 hours after delivery. ]
    Time of first breast feeding.

  2. The proportion of neonates with breast feeding. [ Time Frame: At 24 hours after delivery. ]
    The proportion of neonates with breast feeding.

  3. 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.

  4. Length of stay in hospital after delivery. [ Time Frame: From childbirth up to 30 days after delivery. ]
    Length of stay in hospital after delivery.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03336541


Locations
China, Beijing
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

Publications:

Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03336541     History of Changes
Other Study ID Numbers: 2017[36]
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Prenatal depression
Ketamine
Cesarean delivery
Postpartum depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Puerperal Disorders
Behavioral Symptoms
Mood Disorders
Mental 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