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

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
  • Placebo (DRUG)
    Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.

Condition or Disease

  • Perinatal Depression
  • Ketamine
  • Cesarean Delivery
  • Postpartum Depression

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 64 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 23, 2017 ACTUAL
    Primary Completion: May 14, 2018 ACTUAL
    Completion Date: Jun 25, 2018 ACTUAL
    Study First Posted: Nov 08, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 10, 2021

    Sponsors / Collaborators

    Lead Sponsor: Peking University First Hospital
    Responsible Party: N/A

    Location

    Beijing, China

    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.

    Participant Groups

    • Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.

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

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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 Outcomes

    • Time of first breast feeding.

    • The proportion of neonates with breast feeding.

    • Duration of neonatal sleep within 24 hours after delivery.

    • Length of stay in hospital after delivery.

    • Postpartum depression is assessed with EPDS at 42 days after childbirth.

    • 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.

    • Incidence of neonatal complications with 42 days after delivery.

    More Details

    NCT Number: NCT03336541
    Other IDs: 2017[36]
    Study URL: https://clinicaltrials.gov/study/NCT03336541
    Last updated: Sep 29, 2023