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

Phase 4

Completed

• Conditions: Postpartum Depression; Ketamine; Perinatal Depression; Cesarean Delivery
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT03336541
• Lead Sponsor: Peking University First Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Study Start: 2017-11-23
• Primary Completion: 2018-05-14
• Study Completion: 2018-06-25
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
Ketamine group	Ketamine	Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time of first breast feeding.	From delivery to 24 hours after delivery.	Time of first breast feeding.
The proportion of neonates with breast feeding.	At 24 hours after delivery.	The proportion of neonates with breast feeding.
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.
Length of stay in hospital after delivery.	From childbirth up to 30 days after delivery.	Length of stay in hospital after delivery.
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.
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.
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.
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.

Trial Locations

Locations (1)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital; 🇨🇳 Beijing, Beijing, China