O42
Conditions
Interventions
Group 1: Adult patients who are able to give consent with preterm premature rupture of the membranes between weeks 20 (0) and 26 (0) of pregnancy and with oligo- / anhydramnios.
Treatment scheme: Sta
Sponsors
Universitätsklinikum Halle Saale, Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin Zentrum für Fetalchirurgie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is healthy neonatal survival as an event time up to one year after birth. Healthy neonatal survival is defined as survival without any of the following complications: • sBPD (bronchopulmonary dysplasia) • intraventricular cerebral hemorrhage III-IV ° (intraventricular hemorrhage -IVH 3–4) • cystic periventricular leukomalacia (cPVL) • Necrotizing enterocolitis with surgical indication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes measures are: • Change of the PPROM delivery interval • Duration of continuous amniotic infusion • Gestational age at birth • birth weight • APGAR Score 1, 5, 10 minutes after birth • Pathology of the placenta and chorioamnion (histological examination immediately after birth) • Umbilical cord blood gases • Number of maternal AEs (until discharge) • Number of AEs neonatal (until discharge) • Occurrence of intrauterine fetal death (time of occurrence, cause) • Perinatal mortality • FIRS • retinopathy • Pneumothorax • Need for a shunt procedure • Orthopedic deformities on the day of birth • SIRS • Duration and type of O2 supplementation • Survival without the following complications after birth on the day of discharge or gestational age week 36 (0): o BPD (bronchopulmonary dysplasia, severe bronchopulmonary dysplasia) o intraventricular cerebral hemorrhage III-IV ° (intraventricular hemorrhage (IVH 3-4) o cystic periventricular leukomalacia (cPVL) o Necrotizing enterocolitis with a surgical indication | — |
Countries
Germany
Contacts
Public ContactGregor Seliger
Universitätsklinikum Halle (Saale) Medizinische Fakultät Martin-Luther-Universität Halle-Wittenberg
Outcome results
None listed