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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine group | Experimental | Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery. |
|
| Placebo group | Placebo Comparator | Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22643605 | Background | Patel M, Bailey RK, Jabeen S, Ali S, Barker NC, Osiezagha K. Postpartum depression: a review. J Health Care Poor Underserved. 2012 May;23(2):534-42. doi: 10.1353/hpu.2012.0037. | |
| 25455250 | Background | Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014 Nov 15;384(9956):1800-19. doi: 10.1016/S0140-6736(14)61277-0. Epub 2014 Nov 14. |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Placebo | Drug | Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery. |
|
|
| 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. |
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| 36570810 | Derived | Wang S, Deng CM, Zeng Y, Ma JH, Qu Y, Wang DX. Single low-dose ketamine infusion for women with prenatal depressive symptoms undergoing cesarean delivery: A pilot randomized trial. Front Surg. 2022 Dec 8;9:1050232. doi: 10.3389/fsurg.2022.1050232. eCollection 2022. |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |