Randomized, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy on Cervical Ripening, Safety, Tolerability and Dose Response of SC Administered Tafoxiparin in Term Pregnant, Nulliparous Women With an Unripe Cervix Undergoing Labor Induction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Dilafor AB
- 入组人数
- 365
- 试验地点
- 7
- 主要终点
- Cervical Ripening Rate, Measured by Bishop Score - Slope
研究概览
简要总结
The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are conclusive in favor of tafoxiparin, the study will continue by adding two additional tafoxiparin dose groups in Section B.
详细描述
Primary objective:
To assess the efficacy of tafoxiparin on cervical ripening.
Secondary objective:
To assess the maternal and neonatal safety, tolerability and dose response of tafoxiparin as a supplement therapy in term pregnant, nulliparous women with an unripe cervix undergoing labor induction
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women of ≥18 and ≤ 64 years of age
- •Nulliparous
- •Unripe cervix with ≤ 4points according to Bishop/Westin score (0-10 points scale)
- •Planned for labor induction after 4-7 days of IMP treatment
- •Examples of diagnosis as a basis for induction:
- •Post term pregnancy (40-41 weeks of gestation)
- •Gestational diabetes
- •Diabetes type 1 - well controlled
- •Pre-eclampsia (BP diastolic <100, systolic <140)
- •Hypertension - well controlled
- •Hepatosis (without clinically significantly elevated serum bile acids)
- •Maternal age ≥ 40 years
- •Humanitarian-psycho social reasons
- •Oligohydramnios
- •Gestational age > 37 weeks confirmed by ultrasound before 21 weeks of gestation
- •Singleton pregnancy
- •Subject is, as per the discretion of the Investigator, able to comply with the requirements of the protocol including an ability to be present at all required controls
- •Subject can understand and sign an informed form
- •Provision of written informed consent
排除标准
- •Subjects who are unable to understand the written and verbal instructions in local language
- •Breech presentation and other abnormal fetal presentations
- •Previous uterine scar
- •Spontaneous rupture of membranes at inclusion
- •Pathologic CTG at inclusion
- •Fetal estimated weight > 2SD of normal fetal estimated weight earlier diagnosed by ultrasound and documented in patient record
- •Mother's BMI > 35 at early pregnancy
- •Known IUGR defined as ≤ 2SD of normal
- •Presence of eclampsia
- •Severe Pre-eclampsia
- •HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
- •Clinically significant vaginal bleeding in need of hospitalization in the third trimester
- •Placenta previa
- •Previously known coagulation disorders (Leiden, heterozygote - OK)
- •Current use of any drugs that interfere with hemostasis (including heparin /LMWH, direct oral anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAID) compounds and vitamin K antagonists.)
- •Current use of acetylsalicylic acid (ASA) compounds or use within the week preceding inclusion
- •Diagnosed with HIV or Acute hepatitis
- •Known history of allergy to standard heparin and/or LMWH heparin
- •History of heparin-induced thrombocytopenia
- •Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study.
- •Current participation in other interventional medicinal treatment studies
- •Subject has a fear of needles which is believed by the Investigator to affect study medication compliance
研究组 & 干预措施
Experimental DF01 high dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
干预措施: DF01 (Drug)
Experimental: DF01 medium dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
干预措施: DF01 (Drug)
Experimental: DF01 low dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
干预措施: DF01 (Drug)
Placebo comparator: PL1
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
干预措施: PL1 (Drug)
结局指标
主要结局
Cervical Ripening Rate, Measured by Bishop Score - Slope
时间窗: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).
Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope. Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency. The score was calculated as the sum of the following 5 categories where each category is scored between 0-2: * Fetal station (0-2) * Cervical diameter at inner meatus (0-2) * Cervical effacement (0-2) * Consistency at inner meatus (0-2) * Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe. Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.
次要结局
未报告次要终点