Clinical TrialParallelKetaminePlaceboCompleted

Single Bolus Low-Dose Ketamine for Prevention of Postpartum Depression After Caesarean Section: A Randomized, Double-Blind, Placebo-Controlled Trial

Prospective double-blind placebo-controlled RCT (Shenzhen Maternity and Child Healthcare Hospital) testing whether a single intra-operative bolus of ketamine 0.25 mg/kg IV (vs 0.9% saline) after umbilical cord clamping during elective caesarean section reduces postpartum depression. Enrolled: 330 ASA I–II parturients (screened 448, analysed 325). Primary outcome: EPDS at 3 days and 6 weeks postpartum. Secondary: NRS pain. Conducted October 2015 – March 2016.

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Target Enrollment
330 participants
Study Type
interventional
Design
Randomized, double Blind

Study Arms & Interventions

Ketamine

experimental

Intravenous ketamine (0.25 mg/kg diluted to 10 mL with 0.9% saline) administered within 5 min following clamping of the neonatal umbilical cord.

Interventions

  • Ketamine0.25 mg/kg
    via IV• single dose• 1 doses total

    diluted to 10 mL with 0.9% saline

Saline

placebo

Intravenous 10 mL of 0.9% saline administered within 5 min following clamping of the neonatal umbilical cord.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    10 mL of 0.9% saline

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment330 participants
  • Timeline
    Start: 2015-10-01
    End: 2016-03-31
  • Compounds
    KetaminePlacebo

Related Publications

PaywallindividualPrimary

Single bolus low-dose of ketamine does not prevent postpartum depression: a randomized, double-blind, placebo-controlled, prospective clinical trial

This randomised-controlled trial (n=330) assessed the efficacy of low-dose ketamine (17.5mg/70kg diluted to 10 mL with 0.9% saline) administered during caesarean section in preventing postpartum depression (PPD). No significant differences were found in the prevalence of PPD between the active group and the placebo group at 3 days and 6 weeks after delivery. Pain scores were significantly different at 6 weeks only.

Published
Journal
Archives of Gynecology and Obstetrics
Authors
Yang, X., Yuantao, L., Xialei, H., Daili, C., Baozuan, S., Daqing, M.

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