Postpartum Depression After Cesarean Delivery: Ketamine as a Preventative Intervention: A Feasibility Pilot-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30
研究概览
简要总结
The investigators plan to randomise participants to receive ketamine or placebo control subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to assess the incidence of postpartum depression. This feasibility pilot study is designed to explore the adequacy of the study procedures and tolerability of the interventions.
详细描述
Postpartum depression (PPD)
PPD is one of the most common perinatal medical complications and can have a detrimental effect on both mother and baby. Suicide exceeds hemorrhage and hypertensive disorders as a cause of maternal mortality and maternal psychopathology interferes with the parent-infant relationship. It has been estimated to have a period prevalence of 19.2% in the first 3 postpartum months. The rapid decline in reproductive hormones is thought to contribute to the development of PPD in susceptible women, although the specific pathogenesis is unknown. The American College of Obstetricians and Gynecologists recommend that all women should be routinely screened for depressive symptoms in the perinatal period.
Risk factors for PPD include:
- Depression during pregnancy • Breastfeeding problems
- Preterm birth/infant admission to neonatal intensive care (NICU)
- Traumatic birth experience
- History of depression
- Anxiety during pregnancy
Ketamine's anti-depressant effect
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)
盲法说明
The ketamine and placebo study injectates (subcutaneous and intravenous) will be prepared, in way that does not allow differentiation, by pharmacy staff who are otherwise uninvolved in the study. Participants will be allocated to groups using a random sequence generator. The patients, investigators and outcome assessors will remain unaware of their group until data collection is complete for all participants.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.
干预措施: Control (Drug)
Ketamine SC
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
干预措施: Ketamine 50 MG/ML (Drug)
Ketamine SC
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.
干预措施: Control (Drug)
Ketamine IVI
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
干预措施: Ketamine 50 MG/ML (Drug)
Ketamine IVI
Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
干预措施: Control (Drug)
结局指标
主要结局
The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30
时间窗: 42 days postpartum
Establish a sufficient burden of disease (\>10%) in our population to warrant a full RCT
Percentage of Eligible Patients Consenting to Participation
时间窗: Through study completion, approximately 9 months
Establish a recruitment rate of greater than 50% to confirm the feasibility of conducting an RCT in our population Twenty-five (20.7%) out of 121 women who were approached consented to participation. 2 were withdrawn with 23 completing participation.
Percentage of Patients With a Complete Dataset
时间窗: Through study completion, approximately 9 months
Ensure that the design of assessments and data collection make it possible to achieve a complete dataset in \>90% of participants
Number of Patients in Study Arms Experiencing One or More Severe Side Effects
时间窗: Through study completion, approximately 9 months
Ascertain that neither of the chosen routes of administration of ketamine are intolerable to patients, as defined as the incidence of one or more severe side effects experienced by \>10% of participants in that study arm.
次要结局
- Dose of Opiate Analgesics Administered(Intraoperative phase, approximately 2 hours)
- Dose of Ketorolac Administered (mg)(Intraoperative phase, approximately 2 hours)
- Maximum Intraoperative Pain (NRS)(Intraoperative phase, approximately 2 hours)
- Adverse Effects(Intraoperative and 2 and 6 hours postoperatively)
- Plasma Concentrations of Ketamine(At baseline and approximately 20, 40 and 100 minutes postpartum)
- Total Opiate Consumption in Morphine Equivalents(In the first 2 days postpartum)
- Prevalence of Intraoperative Hypotension(Intraoperative phase, approximately 2 hours)
- Surgical Site Pain: Numerical Rating Scale (NRS 0-10)(At 2, 6, 24 and 48 hours after delivery and on postpartum days 21 and 42)
- Edinburgh Postpartum Depression Scale (EPDS)(On postpartum days 1, 2, 21 and 42)
- Apgar Scores(At 1 and 5 minutes after delivery)
- Admission to NICU(Postpartum day 1)
- The Number of Participants Achieving Breastfeeding Success(Postpartum days 1 and 2)
- Prevalence of Intraoperative Hypertension(Intraoperative phase, approximately 2 hours)
- Prevalence of Intraoperative Bradycardia(Intraoperative phase, approximately 2 hours)
- Prevalence of Intraoperative Tachycardia(Intraoperative phase, approximately 2 hours)
- Postpartum Anxiety(On day of surgery, and postpartum days 1, 2, 21 and 42)
研究者
David Monks
Asst Prof of Anesthesiology
Washington University School of Medicine