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Amnion Flush Study (BMBF)

Information for patients and referring physicians

Dear colleagues!
Dear patients!

Within the framework of the prospective randomized multicenter BMBF study

"Continuous amniotic infusion via an implanted catheter system in premature rupture of membranes (PPROM) with oligo/anhydramnios between 22+0 and 26+0 SSW“


the effect of a significant prolongation of pregnancy by continuous intrauterine amniotic infusion in patients with classic PPROM on healthy neonatal survival after one year is investigated.

The study is funded by the German Federal Ministry of Education and Research (BMBF).

 

Information video on Amnion Flush Method

developed by Prof. Dr. med. Michael Tchirikov

Amnion Flush Method developed by Prof. Dr. Michael Tchirikov

The recruited patients will be randomized into two groups:

In the intervention group, recruited patients with PPROM (preterm premature rupture of membranes) between 22+0 and 26+0 weeks of gestation will receive the "Tchirikov-Amnion Flush Method": a continuous amniotic infusion with patented artificial amniotic fluid (100 ml/h, 2.4 l/d) via a thin intrauterine catheter with an anchor system (see video) in addition to antibiotic therapy and RDS prophylaxis according to DGGG guidelines.

In the control group, patients receive only antibiotic therapy and IBS prophylaxis according to DGGG guidelines.

The primary objective of the study is to analyze the superiority of continuous intrauterine amniotic infusion compared with standard therapy in the treatment of premature rupture of the bladder between 20+0 to 26+0 SSW.

  • Capable pregnant women between 22+0 SSW to 26+0 SSW and status classic PPROM with oligo/anhydramnios between 20+0 to 26+0 SSW  
  • Pregnant women aged ≥18 years
  • Singleton pregnancy
  • Completed RDS prophylaxis
  • Presence of written informed consent for voluntary participation in the clinical trial

The primary outcome measure is healthy neonatal survival at one year.
Healthy neonatal survival is defined as survival without any of the following complications:

  • sBPD (severe bronchopulmonary dysplasia)
  • intraventricular cerebral hemorrhage III-IV°
  • cystic periventricular leukomalacia

Amnion Flush method:

Step 1: 

Amniocentesis with 22G needle under ultrasound guidance

The amniotic fluid (1-2 ml if possible) will be obtained used 1 mm insulin syringe for the bacteriologic examination

Step 2:

Amnioinfusion
through 22G needle

Amnioinfusion of 300 ml (200-400 ml) through 22G needle.

Amnion Flush Solution (Serumwerk AG, Bernburg, Germany) is licensed for the amnioninfusion from 22/0 week of gestation

Step 3A:

Insertion of the perinatal catheter through 18G needle into the amniotic cavity

Das Fruchtwasser (1-2 ml wenn möglich) wird mit einer 1 mm Insulinspritze für die bakteriologische Untersuchung entnommen.

Step 3B:

Insertion of the perinatal catheter into the amniotic cavity – Sono-View

Step 4:

Connection of the catheter to the infusion system

Needle remove, catheter will be connected to the “luer”-adapter and fixed up using sterile transparent film.

"Dear patients, dear colleagues, please do not hesitate to contact a study center located near you if you have any questions regarding treatment.

Of course, I am also personally available for treatment at the Berlin Center for Prenatal Diagnostics and Fetal Surgery."

Evangelisches Waldkrankenhaus Berlin-Spandau
Klinik für Geburtshilfe und Gynäkoloie

Stadtrandstr. 55, 13589 Berlin

Prof. Dr. med. Michael Tchirikov
Tel. (030) 422068 30 200
E-Mail: michael.tchirikov(at)jsd.de

Prof. Dr. Wejing Li (st. Vertretung)
Tel. (030) 370 22 445
E-Mail: weijing.li@jsd.de

Klinik für Geburtshilfe und Perinatologie, Universitätsklinikum Giessen und Marburg GmbH Standort Marburg Universitätsfrauenklinik Marburg

Baldingerstrasse  35043 Marburg

OÄ Fr. Dr. Corinna Keil
Tel. (06421 )58 69715
E-Mail:  Corinna.Keil@med.uni-marburg.de

Helios Kliniken Schwerin, Fachabteilung Geburtshilfe

Wismarsche Straße 393 – 397
19055 Schwerin

Dr. Stephan Henschen
Tel. (0385) 520 23 00
E-Mail: stephan.henschen@helios-gesundheit.de

UNIVERSITÄTSKLINIKUM Schleswig-Holstein
Leitung Pränataldiagnostik
Frauenklinik Campus Kiel

Arnold-Heller-Straße 3 (Haus 24)   
24105 Kiel
Tel. (0431) 500 21415

Frau Prof. Eckmann-Scholz
E-Mail: Christel.Eckmann-Scholz@uksh.de

OÄ Fr. Dr. Andersen
E-Mail: Kristin.Andresen@uksh.de

Krankenhaus Barmherzige Brüder Regensburg
Prüfeninger Str. 86, 93047 Regensburg

OÄ Fr. Dr. Leichtl
Tel. (0941) 369 95 930
E-Mail: Sibylle.Leichtl@barmherzige-regensburg.de

If you have any further questions or if you are concerned or if you are a referring physician caring for a patient who meets the inclusion criteria for the study, please do not hesitate to contact us at 030/42206830200 or via email info@prenatal-berlin.de

We will be happy to help you. With us you are in the best hands!

Book online

 

 

study director Prof. Michael Tchirikov

Berlin Center for Prenatal Diagnostics and Fetal Surgery
MVZ Evangelisches Waldkrankenhaus

Prof. Dr. med. Michael Tchirikov

Specialist in obstetrics and gynecology
Focus: Special obstetrics and prenatal medicine

Consultation hours

Stadtrandstraße 555
13589 Berlin

Mondays:8 am to 5 pm
Tuesdays:8 am to 5 pm
Wednesdays:Surgery day in the EWK 8 am to 5 pm
Thursdays:8 am to 5 pm
Fridays:8 am to 12pm
 
Telephone: +49 (0)30 - 42206830200
* Legally insured and self-payer