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

Primary Purpose

Perinatal Depression, Ketamine, Cesarean Delivery

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Depression focused on measuring Prenatal depression, Ketamine, Cesarean delivery, Postpartum depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine group

Placebo group

Arm Description

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.

Outcomes

Primary Outcome Measures

The score of postpartum depression at 48 hous after childbirth.
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

Time of first breast feeding.
Time of first breast feeding.
The proportion of neonates with breast feeding.
The proportion of neonates with breast feeding.
Duration of neonatal sleep within 24 hours after delivery.
Duration of neonatal sleep within 24 hours after delivery.
Length of stay in hospital after delivery.
Length of stay in hospital after delivery.
The score of postpartum depression at 42 days after delivery.
Postpartum depression is assessed with EPDS at 42 days after childbirth.
Incidence of postpartum depression 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.
Incidence of maternal complications with 42 days after delivery.
Incidence of maternal complications with 42 days after delivery.
Incidence of neonatal complications with 42 days after delivery.
Incidence of neonatal complications with 42 days after delivery.

Full Information

First Posted
November 6, 2017
Last Updated
December 10, 2021
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03336541
Brief Title
Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
May 14, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, Ketamine, Cesarean Delivery, Postpartum Depression
Keywords
Prenatal depression, Ketamine, Cesarean delivery, Postpartum depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine group
Arm Type
Experimental
Arm Description
Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine hydrochloride
Intervention Description
Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
Primary Outcome Measure Information:
Title
The score of postpartum depression at 48 hous after childbirth.
Description
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.
Time Frame
At 48 hours after delivery.
Secondary Outcome Measure Information:
Title
Time of first breast feeding.
Description
Time of first breast feeding.
Time Frame
From delivery to 24 hours after delivery.
Title
The proportion of neonates with breast feeding.
Description
The proportion of neonates with breast feeding.
Time Frame
At 24 hours after delivery.
Title
Duration of neonatal sleep within 24 hours after delivery.
Description
Duration of neonatal sleep within 24 hours after delivery.
Time Frame
During the first 24 hours after delivery.
Title
Length of stay in hospital after delivery.
Description
Length of stay in hospital after delivery.
Time Frame
From childbirth up to 30 days after delivery.
Title
The score of postpartum depression at 42 days after delivery.
Description
Postpartum depression is assessed with EPDS at 42 days after childbirth.
Time Frame
At 42 days after delivery.
Title
Incidence of postpartum depression at 42 days after delivery.
Description
Postpartum depression is assessed with EPDS at 42 days after childbirth. A EPDS score of 10 or above is defined as postpartum depression.
Time Frame
At 42 days after delivery.
Title
Incidence of maternal complications with 42 days after delivery.
Description
Incidence of maternal complications with 42 days after delivery.
Time Frame
From childbirth up to 42 days after delivery.
Title
Incidence of neonatal complications with 42 days after delivery.
Description
Incidence of neonatal complications with 42 days after delivery.
Time Frame
From childbirth up to 42 days after delivery.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression

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