Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Effect of Continuous Infusion of Tafoxiparin as an Adjunct Treatment to Oxytocin for up to 36 Hours in Term Pregnant, Nulliparous Women to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Dilafor AB
- 入组人数
- 361
- 试验地点
- 12
- 主要终点
- Time from start of infusion of tafoxiparin/placebo until vaginal partus
研究概览
简要总结
The study will be designed as a double-blind, placebo-controlled, parallel-group, dose-finding study with one group treated with placebo and three groups treated with tafoxiparin in three different infusion concentration levels, respectively. The intravenous infusion will be initiated by a pre-defined bolus dose infusion.
详细描述
Primary objective
To assess the dose-response relationship of tafoxiparin on the labor time defined as the time from the start of continuous infusion of tafoxiparin/placebo as an Adjunct Treatment to Oxytocin, until partus in term-pregnant, nulliparous women requiring labor augmentation due to Primary Slow Progress of Labor including prolonged latent phase and Labor Arrest.
Secondary objectives
To assess the safety and efficacy of tafoxiparin based on the safety and secondary efficacy parameters evaluated in the protocol. PK (pharmacokinetic) response in pregnant women during labor.
Methodology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women of ≥18 to ≤45 years of age
- •Nulliparous
- •Gestational age > 36 weeks + 6 days confirmed by ultrasound
- •Experience slow progress of labor including prolonged latent phase and labor arrest (according to the respective definitions) etc
排除标准
- •Subjects with secondary slow progress or secondary labor arrest
- •BMI≥35 during first trimester of pregnancy
- •Breech presentation or other abnormal presentations etc
研究组 & 干预措施
DF01 low dose
The subjects will receive intravenous infusion of DF01 (tafoxiparin) in low dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: DF 01 (Drug)
DF01 low dose
The subjects will receive intravenous infusion of DF01 (tafoxiparin) in low dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: Oxytocin (Drug)
DF01 medium dose
The subjects will receive intravenous infusion of DF01 (tafoxiparin) in medium dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: DF 01 (Drug)
DF01 medium dose
The subjects will receive intravenous infusion of DF01 (tafoxiparin) in medium dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: Oxytocin (Drug)
DF01 high dose
The subjects will receive intravenous infusion of DF01 (tafoxiparin) in high dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: DF 01 (Drug)
DF01 high dose
The subjects will receive intravenous infusion of DF01 (tafoxiparin) in high dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: Oxytocin (Drug)
PL1
The subjects will receive intravenous infusion of placebo as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: Oxytocin (Drug)
PL1
The subjects will receive intravenous infusion of placebo as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
干预措施: Placebo (Drug)
结局指标
主要结局
Time from start of infusion of tafoxiparin/placebo until vaginal partus
时间窗: Interval from start of study drug administration to vaginal delivery (hours, up to 36 hours )
The primary endpoint (time from first infusion to vaginal partus) will be summarized graphically for each treatment group using Kaplan-Meier estimates. In addition to this statistical comparison between the treatments will be performed using the analysis of variance technique.
次要结局
- Safety will be evaluated through rate and frequency of adverse events and serious adverse events(Through study completion ( 6 months, +/-4 weeks after delivery))
- Time from cervical dilatation of 4 cm and progress of labor until vaginal partus(Interval from 4 cm of cervical dilatation to vaginal delivery (hours, up to 36 hours ))
- Uterine hyperstimulation with fetal heart rate changes(From start of study drug administration to any delivery (hours, up to 36 hours))
- Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours of established labor (4 cm of cervical dilation to vaginal partus )(Interval from 4 cm of cervical dilatation to vaginal delivery (hours, up to 36 hours ))
- Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours from start of study drug infusion to vaginal partus(Interval from start of study drug administration to vaginal delivery (hours, up to 36 hours ))
- Proportion of women with caesarean sections(From start of study drug administration to caesarean section (hours, up to 36 hours))
- Proportion of women undergoing instrumental deliveries(From start of study drug administration to instrumental delivery (hours, up to 36 hours))
- Use of analgesia (N2O, epidural, pudendal nerve block)(From start of study drug administration to any delivery (hours, up to 36 hours))
- Proportion of women with postpartum hemorrhage > 1000 ml(From start of study drug administration and up to 7 days or discharge whichever comes first (days))
- Fetal outcome measured as Apgar score (5 min) ≤ 7 points, Base Excess > -12 and referral to NICU (neonatal intensive care unit) (for > 48 hours(From start of study drug administration and up to 7 days or discharge whichever comes first (days))
- Indication for referral to NICU(From start of study drug administration through study completion (6 months +- 4 weeks after delivery))
- Use of Oxytocin (no. of mls. according to instructions)(From start of study drug administration to any delivery (hours, up to 36 hours))
- Pharmacokinetic response(From start of study drug administration to any delivery (hours, up to 36 hours))