Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial
| Autor: | Thomas Schmitz, Claire Poyart, Gilles Kayem, Yvon Chitrit, Philippe Bouhanna, Cécile Bébéar, François Goffinet, Elie Azria, Bruno Carbonne, Laurent Mandelbrot, Alexandra Doloy, Alexandra Benachi, Jean Marie Jouannic, Florence Fenollar, Françoise Maillard |
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| Přispěvatelé: | Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Descartes - Paris 5 (UPD5), Sorbonne Université (SU), Sorbonne Université - Faculté de Médecine (SU FM), Unité de Diagnostic Anténatal : Service de Gynécologie Obstétrique [Hôpital Intercommunal de Créteil], CHI Créteil, Hôpital Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Université Paris Diderot - Paris 7 (UPD7), Hôpital Robert Debré, Hôpital Louis Mourier - AP-HP [Colombes], CHI Poissy-Saint-Germain, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Trousseau [APHP], Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Antoine Béclère, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CIC - CHU Bichat, Institut National de la Santé et de la Recherche Médicale (INSERM), Vecteurs - Infections tropicales et méditerranéennes (VITROME), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut de Recherche Biomédicale des Armées [Brétigny-sur-Orge] (IRBA), Université de Bordeaux (UB), Université Sorbonne Paris Cité (USPC), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut de Recherche Biomédicale des Armées (IRBA), COMBE, Isabelle, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC), Institut de Recherche Biomédicale des Armées (IRBA)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU), Hopital Louis Mourier - AP-HP [Colombes], CHU Saint-Antoine [APHP], Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Amniotic fluid
Preterm labor Physiology Maternal Health lcsh:Medicine Artificial Gene Amplification and Extension medicine.disease_cause Pathology and Laboratory Medicine Ureaplasma 0302 clinical medicine Mycoplasma Pregnancy [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases Medicine and Health Sciences 030212 general & internal medicine lcsh:Science Immune Response education.field_of_study 030219 obstetrics & reproductive medicine Multidisciplinary biology medicine.diagnostic_test Obstetrics Obstetrics and Gynecology 3. Good health Anti-Bacterial Agents Body Fluids Polymerase chain reaction Ureaplasma parvum Amniocentesis [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases Premature Birth Female Anatomy Research Article Adult medicine.medical_specialty Population Immunology Mollicutes Mycoplasma hominis [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics Research and Analysis Methods 03 medical and health sciences Signs and Symptoms Diagnostic Medicine medicine Humans education Molecular Biology Techniques Molecular Biology Inflammation Bacteria business.industry lcsh:R Organisms Biology and Life Sciences Neonates Preterm birth medicine.disease biology.organism_classification Pregnancy Complications [SDV.MHEP.GEO] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics Birth Women's Health lcsh:Q business Ureaplasma urealyticum Developmental Biology |
| Zdroj: | PLoS ONE PLoS ONE, 2018, 13 (11), pp.e0206290. ⟨10.1371/journal.pone.0206290⟩ PLoS ONE, Public Library of Science, 2018, 13 (11), pp.e0206290. ⟨10.1371/journal.pone.0206290⟩ PLoS ONE, Vol 13, Iss 11, p e0206290 (2018) Plos One 11 (13), 1-13. (2018) |
| ISSN: | 1932-6203 |
| Popis: | Objective To assess whether antibiotics used for treatment in asymptomatic second-trimester women positive for Mycoplasma or Ureaplasma spp. detected by amniotic-fluid PCR prevents preterm delivery.[br/] Design A randomized, double-blind, placebo-controlled trial.[br/] Setting 10 maternal fetal medicine centers in France.[br/] Population Women with a singleton pregnancy who underwent amniocentesis between 16 and 20 weeks’ gestation (weeks) for Down syndrome screening. A sample of 238 women with PCR-positive findings per treatment group was needed to show a 50% reduction in the preterm delivery rate.[br/] Methods Amniotic fluid was tested. Women with positive findings on real-time PCR of amniotic fluid for Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum and Ureaplasma parvum were randomized to receive josamycin or placebo. Amniotic fluid was also tested for 16S PCR.[br/] Main outcome measures The primary outcome was delivery before 37 weeks.[br/] Results In total, 1043 women underwent amniotic-fluid screening with specific PCR detection between July 2008 and July 2011: PCR detection failed in 27 (2.6%), and 20 (1.9%) underwent termination of pregnancy. Among the 1016 women with PCR results, 980 had available data for the primary outcome (delivery before 37 weeks) and 29 (3.0%) were positive for Ureaplasma and/or Mycoplasma spp. Because of the low rate of women with PCR-positive findings, the trial was stopped prematurely. In total, 19 women were randomized to receive placebo (n = 8) or josamycin (n = 11) and their characteristics were comparable, as was the rate of preterm delivery and secondary outcomes. In comparing all PCR-positive and -negative women regardless of treatment, PCR positivity for Ureaplasma and/or Mycoplasma spp. was not associated with any adverse pregnancy or neonatal outcome. Amniotic-fluid screening by 16S PCR showed no other bacterial colonization associated with preterm birth.[br/] Conclusions Because of a low amniotic fluid colonization rate, the trial was interrupted. Maternal amniotic-fluid colonization by Mycoplasma and/or Ureaplasma spp. at 16–20 weeks in asymptomatic women is rare and not associated with adverse pregnancy outcomes.[br/] Trial registration ClinicalTrials.gov NCT00718705 |
| Databáze: | OpenAIRE |
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