Evidence map›Paper›PMID 36143388›Full record

ArticleLife (Basel, Switzerland)2022

Treatment of Classic Mid-Trimester Preterm Premature Rupture of Membranes (PPROM) with Oligo/Anhydramnion between 22 and 26 Weeks of Gestation by Means of Continuous Amnioinfusion: Protocol of a Randomized Multicentric Prospective Controlled TRIAL and Review of the Literature.

Michael Tchirikov, Christian Haiduk, Miriam Tchirikov, Marcus Riemer, Michael Bergner, Weijing Li, Stephan Henschen, Michael Entezami, Andreas Wienke, Gregor Seliger

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Life (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04696003 (Treatment of Classic Mid-trimester Preterm Premature Rupture of Membranes), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04696003 phase3unknown statusnot on this map

Treatment of Classic Mid-trimester Preterm Premature Rupture of Membranes (PPROM) With Oligo/Anhydramnion Between 22/0-26/0 Week of Gestation by Means of Continuous Amnioinfusion: a Multicenter Prospectiv Randomized Trial

TypeinterventionalSponsorMartin-Luther-Universität Halle-WittenbergRan2021 to 2025Enrolled68ConditionsBronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intracranial HemorrhagesArmsContinuous amnioinfusion with Amnion Flush Solution through the intraamniotic catheter
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Michael TchirikovClinic of Obstetrics and Prenatal Medicine, Center of Fetal Surgery, University Hospital Halle (Saale), Martin-Luther-University Halle-Wittenberg, 06120 Halle (Saale), Germany.ORCID 0000-0001-7638-0730
Christian HaidukCenter of Clinical Studies, Martin Luther University Halle-Wittenberg, 06108 Halle (Saale), Germany.
Miriam TchirikovClinic of Obstetrics and Prenatal Medicine, Center of Fetal Surgery, University Hospital Halle (Saale), Martin-Luther-University Halle-Wittenberg, 06120 Halle (Saale), Germany.
Marcus RiemerClinic of Obstetrics and Prenatal Medicine, Center of Fetal Surgery, University Hospital Halle (Saale), Martin-Luther-University Halle-Wittenberg, 06120 Halle (Saale), Germany.ORCID 0000-0001-6978-6513
Michael BergnerClinic of Obstetrics and Prenatal Medicine, Center of Fetal Surgery, University Hospital Halle (Saale), Martin-Luther-University Halle-Wittenberg, 06120 Halle (Saale), Germany.
Weijing LiClinic of Obstetrics and Gynecology, St. Joseph Krankenhaus Berlin Tempelhof, 12101 Berlin, Germany.
Stephan HenschenClinic of Obstetrics and Gynecology, Hamburg Medical School, Helios Clinics GmbH, 19049 Schwerin, Germany.
Michael EntezamiCenter of Prenatal Diagnostic and Human Genetic, 10719 Berlin, Germany.
Andreas WienkeInstitute of Medical Epidemiology, Biostatistics and Informatics, Martin-Luther-University Halle-Wittenberg, 06120 Halle (Saale), Germany.
Gregor SeligerClinic of Obstetrics and Prenatal Medicine, Center of Fetal Surgery, University Hospital Halle (Saale), Martin-Luther-University Halle-Wittenberg, 06120 Halle (Saale), Germany.ORCID 0000-0001-6201-9303
Martin Luther University Halle-Wittenberg · DEHelios Hospital Schwerin · DEZentrum für Pränataldiagnostik · DESt. Joseph-Krankenhaus · DE

Funding

Federal Ministry of Education and Research 01KG2007
6 · The paper itself

Abstract

backgroundThe classic mid-trimester preterm premature rupture of membranes (PPROM) is defined as a rupture of the fetal membranes prior to 28 weeks of gestation (WG) with oligo/anhydramnion; it complicates approximately 0.4-0.7% of all pregnancies and is associated with very high neonatal mortality and morbidity. Antibiotics have limited success to prevent bacterial growth, chorioamnionitis and fetal inflammation. The repetitive amnioinfusion does not work because fluid is lost immediately after the intervention. The continuous amnioinfusion through the transabdominal port system or catheter in patients with classic PPROM shows promise by flushing out the bacteria and inflammatory components from the amniotic cavity, replacing amniotic fluid and thus prolonging the PPROM-to-delivery interval.

objectiveThis multicenter trial aims to test the effect of continuous amnioinfusion on the neonatal survival without the typical major morbidities, such as severe bronchopulmonary dysplasia, intraventricular hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis one year after the delivery. STUDY

designWe plan to conduct a randomized multicenter trial with a two-arm parallel design. Randomization will be between 22/0 and 26/0 SSW. The control group: PPROM patients between 20/0 and 26/0 WG who will be treated with antibiotics and corticosteroids (from 22/0 SSW) in accordance with the guidelines of German Society of Obstetrics and Gynecology (standard PPROM therapy). In the interventional group, the standard PPROM therapy will be complemented with the Amnion Flush Method, with the amnioinfusion of Amnion Flush Solution through the intra-amnial catheter (up to 100 mL/h, 2400 mL/day). SUBJECTS: The study will include 68 patients with classic PPROM between 20/0 and 26/0 WG. TRIAL-REGISTRATION: ClinicalTrials.gov ID: NCT04696003. GERMAN CLINICAL TRIALS REGISTER: DRKS00024503, January 2021.

Indexed as

amnioinfusionAmnion Flush Methodanhydramnionneonatal survivalPPROMpreterm premature rupture of membranes

Identifiers

PMID36143388
PMCPMC9500795
OpenAlexW4293773012

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.