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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Perinatal Depression, Ketamine, Cesarean Delivery, Postpartum Depression

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine group<br>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<br>* Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.<br>* Other names: Ketamine hydrochloride;|
| Placebo Comparator: Placebo group<br>Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery. | Drug: Placebo<br>* Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 48 hours after delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of first breast feeding. | Time of first breast feeding. | From delivery to 24 hours after delivery. | 
| The proportion of neonates with breast feeding. | The proportion of neonates with breast feeding. | At 24 hours after delivery. | 
| Duration of neonatal sleep within 24 hours after delivery. | Duration of neonatal sleep within 24 hours after delivery. | During the first 24 hours after delivery. | 
| Length of stay in hospital after delivery. | Length of stay in hospital after delivery. | From childbirth up to 30 days after delivery. | 
| The score of postpartum depression at 42 days after delivery. | Postpartum depression is assessed with EPDS at 42 days after childbirth. | At 42 days after delivery. | 
| 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. | At 42 days after delivery. | 
| Incidence of maternal complications with 42 days after delivery. | Incidence of maternal complications with 42 days after delivery. | From childbirth up to 42 days after delivery. | 
| Incidence of neonatal complications with 42 days after delivery. | Incidence of neonatal complications with 42 days after delivery. | From childbirth up to 42 days after delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal depression, Ketamine, Cesarean delivery, Postpartum depression