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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

Background: The 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 mortalit...

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Autores principales: Tchirikov, Michael, Haiduk, Christian, Tchirikov, Miriam, Riemer, Marcus, Bergner, Michael, Li, Weijing, Henschen, Stephan, Entezami, Michael, Wienke, Andreas, Seliger, Gregor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9500795/
https://www.ncbi.nlm.nih.gov/pubmed/36143388
http://dx.doi.org/10.3390/life12091351
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author Tchirikov, Michael
Haiduk, Christian
Tchirikov, Miriam
Riemer, Marcus
Bergner, Michael
Li, Weijing
Henschen, Stephan
Entezami, Michael
Wienke, Andreas
Seliger, Gregor
author_facet Tchirikov, Michael
Haiduk, Christian
Tchirikov, Miriam
Riemer, Marcus
Bergner, Michael
Li, Weijing
Henschen, Stephan
Entezami, Michael
Wienke, Andreas
Seliger, Gregor
author_sort Tchirikov, Michael
collection PubMed
description Background: The 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. Objective: This 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 Design: We 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.
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spelling pubmed-95007952022-09-24 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 Tchirikov, Michael Haiduk, Christian Tchirikov, Miriam Riemer, Marcus Bergner, Michael Li, Weijing Henschen, Stephan Entezami, Michael Wienke, Andreas Seliger, Gregor Life (Basel) Study Protocol Background: The 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. Objective: This 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 Design: We 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. MDPI 2022-08-30 /pmc/articles/PMC9500795/ /pubmed/36143388 http://dx.doi.org/10.3390/life12091351 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Tchirikov, Michael
Haiduk, Christian
Tchirikov, Miriam
Riemer, Marcus
Bergner, Michael
Li, Weijing
Henschen, Stephan
Entezami, Michael
Wienke, Andreas
Seliger, Gregor
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9500795/
https://www.ncbi.nlm.nih.gov/pubmed/36143388
http://dx.doi.org/10.3390/life12091351
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