Clinical TrialPostpartum DepressionKetaminePlaceboCompleted

Low-dose Ketamine and Postpartum Depression in 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.

Target Enrollment
64 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, double-arm, placebo-controlled trial testing whether a single low-dose ketamine infusion given after childbirth during elective cesarean delivery reduces incidence of postpartum depression in parturients with prenatal depression (EPDS ≥10).

Participants receive either ketamine 0.5 mg/kg in 100 ml normal saline or placebo (100 ml normal saline) infused IV over 40 minutes after delivery; outcomes include postpartum depression incidence and safety measures.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Low-dose ketamine IV infusion (0.5 mg/kg) after childbirth during cesarean delivery.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    0.5 mg/kg in 100 ml normal saline infused intravenously over 40 minutes after childbirth during cesarean delivery.

Placebo

placebo

Normal saline IV infusion as placebo comparator.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    100 ml normal saline infused intravenously over 40 minutes after childbirth during cesarean delivery.

Participants

Ages
18 – 45
Sexes
female

Inclusion 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

  • 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.

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment64 participants
  • Timeline
    Start: 2017-11-23
    End: 2018-06-25
  • Compounds
    KetaminePlacebo
  • Topic
    Postpartum Depression

Locations

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital — Beijing, Beijing Municipality, China

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