临床试验/NCT00710242

NCT00710242已完成2 期

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Assess the Safety and Efficacy or Pre-Treatment With DF01 During Late Pregnancy in Reducing Prolonged Labor

Dilafor AB15 个研究点分布在 1 个国家目标入组 263 人开始时间: 2007年4月最近更新: 2009年5月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Dilafor AB
入组人数: 263
试验地点: 15
主要终点: Time from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes until partus in women with vaginal delivery

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time to delivery will be measured from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes.

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 40 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•healthy nulliparous females
•normal singleton pregnancy
•intact membranes

排除标准

•breech or other abnormal presentation
•intercurrent illness
•pregnancy complications
•vaginal bleeding in third trimester

研究组 & 干预措施

1

Experimental

DF01

干预措施: DF01 (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Time from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes until partus in women with vaginal delivery

时间窗: See above

次要结局

Complications of labor(At delivery)

研究者

发起方

Dilafor AB

申办方类型

Industry

研究点 (15)

Loading locations...

相似试验

已完成

1 期

Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's DiseaseAlzheimer's Disease

NCT02600130Longeveron Inc.33

已完成

1 期

A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy ParticipantsHealthy Volunteers

NCT05670704argenx112

已完成

1 期

A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 VaccineCOVID-19 Respiratory InfectionCOVID-19 Vaccine Adverse Reaction

NCT05685953Matti Sällberg16

已完成

2 期

Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative IleusIleus

NCT05056935Newsoara Biopharma Co., Ltd.131

已完成

2 期

A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel ResectionIleusPost-Operative Adhesions

NCT02836470Palisade Bio112