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| Name | Class |
|---|---|
| Peking University International Hospital | OTHER |
| Hunan Provincial Maternal and Child Health Care Hospital | OTHER |
| Nanjing Medical University | OTHER |
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Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.
Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-katamine group | Experimental | For women in this group, study drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward. |
|
| Placebo group | Placebo Comparator | For women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-ketamine | Drug | S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of depression at 42 days after childbirth. | PDepression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0. | At 42 days after childbirth. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal depression score at 7 days postpartum. | Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview. | At 7 days after childbirth. |
| Maternal depression score at 42 days postpartum. |
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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 |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Beijing Tiantan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9559758 | Background | Nonacs R, Cohen LS. Postpartum mood disorders: diagnosis and treatment guidelines. J Clin Psychiatry. 1998;59 Suppl 2:34-40. | |
| 24239932 | Background | Kim S, Soeken TA, Cromer SJ, Martinez SR, Hardy LR, Strathearn L. Oxytocin and postpartum depression: delivering on what's known and what's not. Brain Res. 2014 Sep 11;1580:219-32. doi: 10.1016/j.brainres.2013.11.009. Epub 2013 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 |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Women's Hospital School Of Medicine Zhejiang University |
| OTHER |
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| Placebo | Drug | Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth. |
|
|
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview. |
| At 42 days after childbirth. |
| Maternal depression severity at 42 days postpartum. | Maternal depression severity will be assessed with the Hamilton Depression Scale-17 | At 42 days after childbirth. |
| Intensity of pain at 1, 7, and 42 days postpartum. | Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain). | At 1, 7, and 42 days after childbirth. |
| Maternal breast feeding at 1, 7, and 42 days postpartum. | The mode of baby feeding include breast feeding, mixed feeding, or formula feeding. | At 1, 7, and 42 days after childbirth. |
| Length of hospital stay after giving birth. | Length of hospital stay after giving birth. | Up to 30 days after giving birth. |
| Incidence of maternal complications within 42 days postpartum. | Maternal complications are defined as those that are harmful to maternal health and require medical intervention. | Up to 42 days after giving birth. |
| Incidence of neonatal diseases within 42 days. | Neonatal diseases are defined as those that require medical intervention. | Up to 42 days after birth. |
| Beijing |
| Beijing Municipality |
| China |
| Peking University International Hospital | Beijing | Beijing Municipality | China |
| Hunan Provincial Maternal and Child Health Care Hospital | Changsha | Hunan | China |
| Huaian Maternal and Child Health Care Hospital | Huaian | Jiangsu | China |
| Nanjing Maternal and Child Health Care Hospital | Nanjing | Jiangsu | China |
| Women's Hospital School Of Medicine Zhejiang University | Hanzhou | Zhejiang | China |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |