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
Verified date | December 2021 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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* Note: There are 24 references in all — Click here to view all references
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. |
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