Low-dose S-ketamine in Women With Prenatal Depression
- Conditions
- Prenatal DepressionKetaminePostpartum Depression
- Interventions
- Drug: Placebo
- Registration Number
- NCT04414943
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 364
- Maternal age ≥18 years;
- Prenatal Edinburgh postnatal depression scale score ≥10 points.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-katamine group S-ketamine 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 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.
- Primary Outcome Measures
Name Time Method The incidence of depression at 42 days postpartum. At 42 days after childbirth. Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
- Secondary Outcome Measures
Name Time Method Incidence of neonatal diseases within 42 days. Up to 42 days after birth. Neonatal diseases are defined as those that require medical intervention.
Maternal depression score at 7 days postpartum. At 7 days 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 telephone interview.
Maternal depression score at 42 days postpartum. At 42 days 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.
Intensity of pain at 1, 7, and 42 days postpartum. At 1, 7, and 42 days after childbirth. Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
Maternal breast feeding at 1, 7, and 42 days postpartum. At 1, 7, and 42 days after childbirth. The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Length of hospital stay after giving birth. Up to 30 days after giving birth. Length of hospital stay after giving birth.
Incidence of maternal complications within 42 days postpartum. Up to 42 days after giving birth. Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Maternal depression severity at 42 days postpartum. At 42 days after childbirth. Maternal depression severity will be assessed with the Hamilton Depression Scale-17 (HAMD; score range 0-52, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Trial Locations
- Locations (7)
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China
Huaian Maternal and Child Health Care Hospital
🇨🇳Huaian, Jiangsu, China
Nanjing Maternal and Child Health Care Hospital
🇨🇳Nanjing, Jiangsu, China
Peking University International Hospital
🇨🇳Beijing, Beijing, China
Hunan Provincial Maternal and Child Health Care Hospital
🇨🇳Changsha, Hunan, China
Women's Hospital School Of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China