EUCTR2016-002118-40-SE进行中（未招募）1 期
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 Primary Labor Arrest
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
- 360
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
入选标准
- •1.Pregnant women of =18 to =45 years of age
- •2.Nulliparous
- •3.Gestational age > 36 weeks + 6 days confirmed by ultrasound
- •4.Experience slow progress of labor including prolonged latent phase and Primary labor arrest (according to the respective definitions)
- •5.Normal CTG at inclusion
- •6.Singleton pregnancy
- •7.Subject is as per the discretion of the Investigator, considered healthy and able to comply with the requirements of the protocol
- •8.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 360
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant women of =18 to =45 years of age
- •2.Nulliparous
- •3.Gestational age > 36 weeks + 6 days confirmed by ultrasound
- •4.Experience slow progress of labor including prolonged latent phase and Primary labor arrest (according to the respective definitions)
- •5.Normal CTG at inclusion
- •6.Singleton pregnancy
- •7.Subject is as per the discretion of the Investigator, considered healthy and able to comply with the requirements of the protocol
- •8.Provision of written informed consent
- •1.Subjects with secondary slow progress or secondary labor arrest
- •2.BMI=35 during first trimester of pregnancy
- •3.Breech presentation or other abnormal presentations
- •4.LGA (Large for Gestational Age) defined as = to normal weight earlier diagnosed by ultrasound and documented in patient record
- •5.Small for gestational age (SGA) defined as =-2SD to normal weight earlier diagnosed by ultrasound and documented in patient record
- •6.Presence of eclampsia
- •7.Severe preeclampsia, defined as severe by the [ACOG Committee Preeclampsia and Eclampsia (2002)] as preeclampsia with any or more of the following characteristics present:
- •- Blood pressure of =160 mmHg systolic or =110 mmHg diastolic on two occasions at least 6 hours apart while the patient is on bed rest
- •- Proteinuria of 5 g or higher in a 24-hour urine specimen or 3+ greater on two random urine samples collected at least 4 hours apart
- •- Oliguria of less than 500 mL in 24 hours
- •- Cerebral or visual disturbances
- •- Pulmonary edema or cyanosis
- •- Epigastric or right upper-quadrant pain
- •- Impaired liver function
- •- Thrombocytopenia
- •8.HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
- •9.Clinically significant vaginal bleeding in the third trimester
- •10.Diagnosed renal insufficiency
- •11.Previously known coagulation disorders, including but not limited to:
- •- Von Willebrand’s disease
- •- Haemophilia A/B
- •- Antithrombin deficiency
- •- Vitamin K deficiency
- •12.Previously known coagulation defects, including but not limited to:
- •- Prolonged activated partial thromboplastin time (APTT)
- •- Thrombocytes <100 x 109/L
- •13.Current use of any drugs that interfere with hemostasis, including heparin / LMWH, non-steroidal anti-inflammatory drugs (NSAID) compounds, warfarin and vitamin K antagonists
- •14.Current use, or use within the week preceding screening, of acetylsalicylic acid (ASA) compounds
- •15.Previously known current infections (HIV or hepatitis)
- •16.Any known history of allergy to standard heparin and/or LMWH heparin
- •17.History of heparin-induced thrombocytopenia
- •18.Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study
- •19.Current participation in other clinical treatment studies
- •20.Previous uterine scar (e.g. myomectomy)
研究者
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