DRKS00024503进行中（未招募）3 期
Continuous amnion infusion via an implanted catheter system in the case of classic preterm premature rupture of membranes (PPROM) with oligo- / anhydramnion between 22+ 0 and 26 + 0 weeks of gestation: a multicenter prospective controlled clinical study - Flush-Out-PPROM
niversitätsklinikum Halle Saale, Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin Zentrum für Fetalchirurgie0 个研究点目标入组 19 人开始时间: 2021年3月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •Pregnant women capable of giving consent between the 22 + 0 week of gestation to 26 + 0 week of pregnancy with classic PPROM and oligo- / anhydramnios
- •Pregnant women aged =18 years
- •Singleton pregnancies
- •Completed RDS prophylaxis
- •written consent for voluntary participation in the clinical trial
排除标准
- •Occurrence of a single PPROM without leakage of amniotic fluid in the form of an oligo- / anhydramnion
- •pre-PPROM
- •Occurrence of a PPROM with oligo / anhydramnios before 20 + 0 and after 26 + 0 weeks of gestation
- •PPROM more than 14 days ago
- •CRP> 20 mgl / L
- •known fetal chromosomal abnormalities
- •Intrauterine drug application
- •severe fetal malformations
- •Signs of prematurity
- •Signs of intrauterine infection or inflammation or both, especially triple I:
- •o maternal fever of unknown origin (if the orally measured temperature is above 38.0 ° C
- •AND ONE of the following:
- •o fetal tachycardia over 160 beats per min. for> 10 min.
- •o Maternal leukocytes> 15,000 / microliter without administration of corticosteroids
- •o purulent fluoride from the cervix
- •o maternal tachycardia> 100 bpm
- •intrauterine fetal death
- •Indication for termination of pregnancy, e.g. HELLP syndrome, pathological CTG, eclampsia, umbilical cord proplapse
- •Cervical insufficiency (shortening of the cervix to less than 2.5 cm)
- •Meconium finish
- •IUGR <5 percentile with pathological Doppler
- •Placenta previa
- •(Partial) premature placenta detachment
- •known maternal chronic infection with HIV, active Hep B, C
- •Severe autoimmune diseases (e.g. rheumatic such as lupus e., Psoriasis) or immunosuppressive therapy due to the above-mentioned or hematological underlying diseases
- •known multi-resistant infection / colonization
- •any other medical or psychological impairment which, in the medical judgment, precludes participation in this study
- •Persons accommodated in an institution on the basis of a court or official order (AMG §40, Paragraph 1, No. 4)
- •Participation in another clinical trial at the same time or up to 30 days before inclusion (with the exception of observational studies and registry studies)
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