Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 7
- 主要终点
- The incidence of depression at 42 days after childbirth.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients with age ≥18 years;
- •Presence of prenatal depression (EPDS score ≥10);
排除标准
- •A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
- •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;
- •American Society of Anesthesiologists classification ≥III;
- •Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.
研究组 & 干预措施
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.
干预措施: S-ketamine (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of depression at 42 days after childbirth.
时间窗: 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.
次要结局
- Maternal depression score at 42 days postpartum.(At 42 days after childbirth.)
- Intensity of pain at 1, 7, and 42 days postpartum.(At 1, 7, and 42 days after childbirth.)
- Maternal breast feeding at 1, 7, and 42 days postpartum.(At 1, 7, and 42 days after childbirth.)
- Length of hospital stay after giving birth.(Up to 30 days after giving birth.)
- Incidence of maternal complications within 42 days postpartum.(Up to 42 days after giving birth.)
- Incidence of neonatal diseases within 42 days.(Up to 42 days after birth.)
- Maternal depression score at 7 days postpartum.(At 7 days after childbirth.)
- Maternal depression severity at 42 days postpartum.(At 42 days after childbirth.)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital