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

Postpartum Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336541
• Other study ID #: 2017[36]
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: December 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 25, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Delivery
• Depression
• Depression, Postpartum
• Depressive Disorder
• Ketamine
• Perinatal Depression
• Postpartum Depression

Intervention

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.
• Placebo
Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.

Locations

Country	Name	City	State
China	Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time of first breast feeding.	Time of first breast feeding.	From delivery to 24 hours after delivery.
Secondary	The proportion of neonates with breast feeding.	The proportion of neonates with breast feeding.	At 24 hours after delivery.
Secondary	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.
Secondary	Length of stay in hospital after delivery.	Length of stay in hospital after delivery.	From childbirth up to 30 days after delivery.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.