Study Results
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Basic Information
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COMPLETED
NA
364 participants
INTERVENTIONAL
2020-06-19
2022-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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S-katamine group
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.
S-ketamine
For women in this group, active 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. They will be monitored for 60 minutes and then sent back to the ward.
Placebo group
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.
Placebo
For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
Interventions
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S-ketamine
For women in this group, active 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. They will be monitored for 60 minutes and then sent back to the ward.
Placebo
For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prenatal Edinburgh postnatal depression scale score ≥10 points.
Exclusion Criteria
2. Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
3. American Society of Anesthesiologists classification ≥III;
4. Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.
18 Years
FEMALE
No
Sponsors
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Peking University International Hospital
OTHER
Hunan Provincial Maternal and Child Health Care Hospital
OTHER
Nanjing Medical University
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
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
Hangzhou, Zhejiang, China
Countries
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References
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Other Identifiers
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2019[336]
Identifier Type: -
Identifier Source: org_study_id
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