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
- Conditions
- O42Premature rupture of membranes
- Registration Number
- DRKS00024503
- Lead Sponsor
- niversitätsklinikum Halle Saale, Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin Zentrum für Fetalchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Female
- Target Recruitment
- 19
• 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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is healthy neonatal survival as an event time up to one year after birth.<br> <br>Healthy neonatal survival is defined as survival without any of the following complications:<br><br>• sBPD (bronchopulmonary dysplasia)<br>• intraventricular cerebral hemorrhage III-IV ° (intraventricular hemorrhage -IVH 3–4)<br>• cystic periventricular leukomalacia (cPVL)<br>• Necrotizing enterocolitis with surgical indication
- Secondary Outcome Measures
Name Time Method