ACTRN12617000176369尚未招募4 期
Correlative assessment of prophylactic oxytocin pharmacokinetics (PK) to maternal body mass index (BMI) following intravenous (IV) and intramuscular (IM) administration, for the prevention of postpartum haemorrhage, at elective caesarean section. An open label, prospective, exploratory, randomised controlled trial.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- Female
入选标准
- •1) A Body Mass Index (BMI) classified as either: normal range, (BMI 18.5-24.99 Kg/m2), overweight/pre-obese (BMI 25.00-29.99 Kg/m2), obese class I (BMI 30-34.99 Kg/m2) obese class II (BMI 35-39 Kg/m2) or obese class III (equal to, or more than, 40.00 Kg/m2), at booking
- •2) Singleton pregnancy
- •3) Live fetus
- •4) Full term pregnancy (equal to, or more than, 37 weeks)
- •5) Mode of birth: elective lower segment caesarean section (LUSCS) (no labour) or a vaginal birth (following labour)
- •6) Parity: 3, or less, at time of recruitment (antenatal)
- •7) Haemoglobin (Hb) equal to, or more than, 100g/L
- •8) 18-40 years of age
- •9) Capacity to provide written, informed consent.
排除标准
- •1) A Body Mass Index (BMI) classified as either: underweight <18.5 Kg/m2, at booking
- •2) Prior to birth, where it is already known that there will be a clinical indication for the administration of Syntometrine ('Registered Trademark') and/or Ergometrine for the routine management of the third stage of labour
- •3) A diagnosis of Type I insulin dependent diabetes (IDDM)
- •4) General anaesthesia for caesarean section
- •5) A recipient of an intra-partum oxytocin intravenous infusion (IVI)
- •6) A requirement for an emergency caesarean section
- •7) <37 completed weeks of pregnancy
- •8) Previous hypersensitivity/adverse reaction to oxytocin (Syntocinon 'Registered Trademark') or any of the excipients in its formulation
- •9) Evidence of hepatic or renal dysfunction, demonstrated by abnormalities in pathology reports and/or documentation in hospital records
- •10) The presence of hypertension requiring IV therapy
- •11) Presence of maternal cardiac disease/arrhythmias, where a reduced dose of oxytocin maybe advocated
- •12) Unwillingness or inability to follow the procedures outlined in the Participant Information and Consent Form
- •13) Mentally, cognitively or legally incapacitated or unable to provide informed consent
- •14) Co-recruitment/participation in another clinical trial where there is pharmaceutical intervention
- •15) Documented, or declared, use of: methadone, buprenorphine and/or illegal drugs during pregnancy
- •16) Presence of (any/all): Hepatitis B Surface Antigen (HBsAg), positive Hepatitis C Antibody Test or Human Immunodeficiency Virus (HIV) Antibody
- •17) Known abnormality of placentation (e.g. placenta praevia, vasa praevia, placental abruption, placenta accreta/incretta/percreta).
研究者
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