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

Sponsor
Peking University First Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03336541
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Nov 23, 2017
Actual Primary Completion Date :
May 14, 2018
Actual Study Completion Date :
Jun 25, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • Normal saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The score of postpartum depression at 48 hous after childbirth. [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. [From delivery to 24 hours after delivery.]

      Time of first breast feeding.

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

      The proportion of neonates with breast feeding.

    3. Duration of neonatal sleep within 24 hours after delivery. [During the first 24 hours after delivery.]

      Duration of neonatal sleep within 24 hours after delivery.

    4. Length of stay in hospital after delivery. [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. [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. [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. [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. [From childbirth up to 42 days after delivery.]

      Incidence of neonatal complications with 42 days after delivery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
    ClinicalTrials.gov Identifier:
    NCT03336541
    Other Study ID Numbers:
    • 2017[36]
    First Posted:
    Nov 8, 2017
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
    Prenatal depression
    Ketamine
    Cesarean delivery
    Postpartum depression
    Additional relevant MeSH terms:
    Depression, Postpartum
    Depression
    Depressive Disorder
    Ketamine

    Study Results

    No Results Posted as of Dec 13, 2021