EUCTR2019-000620-17-FI进行中（未招募）1 期
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, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin as an Adjuvant to Induction Therapy in Term Pregnant, Nulliparous Women with an unripe cervix
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Dilafor AB
- 入组人数
- 334
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •i) Pregnant women of =18 and = 64 years of age
- •ii) Nulliparous
- •iii) Unripe cervix with = 4points according to Bishop/Westin score (0-10
- •points scale)
- •iv) 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)
- •Hepatosis (without clinically significantly elevated serum bile acids)
- •Maternal age 40 years
- •Humanitarian-psycho social reasons
- •Oligohydramnios
- •v) Gestational age > 37 weeks confirmed by ultrasound before 21 weeks of
- •vi) Singleton pregnancy
- •vii) 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
- •viii) Subject can understand and sign an informed form
- •ix) Provision of written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 334
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •i) Subjects who are unable to understand the written and verbal instructions in local language
- •ii) Breech presentation and other abnormal fetal presentations
- •iii) Previous uterine scar
- •iv) Spontaneous rupture of membranes at inclusion
- •v) Pathologic CTG at inclusion
- •vi) Fetal estimated weight > 2SD of normal fetal estimated weight earlier diagnosed by ultrasound and documented in patient record
- •vii) Mother’s BMI > 35 at early pregnancy
- •viii) Known IUGR defined as = 2SD of normal
- •ix) Presence of eclampsia
- •x) Severe Pre-eclampsia
- •xi) HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
- •xii) Clinically significant vaginal bleeding in need of hospitalization in the third trimester
- •xiii) Placenta previa
- •xiv) Previously known coagulation disorders (Leiden, heterozygote - OK)
- •xv) Treatment with a heparin/LMWH product during the previous six months
- •xvi) Current use of any drugs that interfere with hemostasis such as oral anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAID) compounds and vitamin K antagonists.
- •xvii) Current use of acetylsalicylic acid (ASA) compounds or use within the week preceding inclusion
- •xviii) Diagnosed with HIV or Acute hepatitis
- •xix) Known history of allergy to standard heparin and/or LMWH heparin
- •xx) History of heparin-induced thrombocytopenia
- •xxi) Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study.
- •xxii) Current participation in other interventional medicinal treatment studies
- •xxiii) Subject has a fear of needles which is believed by the Investigator to affect study medication compliance
- •xxiv) Any relevant condition, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study
研究者
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