Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT03336541
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
Other names: Ketamine hydrochloride
Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
Other names: Normal saline
Time frame: 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.
Time frame: From delivery to 24 hours after delivery.
Time of first breast feeding.
Time frame: At 24 hours after delivery.
The proportion of neonates with breast feeding.
Time frame: During the first 24 hours after delivery.
Duration of neonatal sleep within 24 hours after delivery.
Time frame: From childbirth up to 30 days after delivery.
Length of stay in hospital after delivery.
Time frame: At 42 days after delivery.
Postpartum depression is assessed with EPDS at 42 days after childbirth.
Time frame: 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.
Time frame: From childbirth up to 42 days after delivery.
Incidence of maternal complications with 42 days after delivery.
Time frame: From childbirth up to 42 days after delivery.
Incidence of neonatal complications with 42 days after delivery.
Peking University First Hospital
Other
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
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