Journal Article

Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial

Maillard, Francoise, Carbonne, Bruno, Schmitz, Thomas, Hôpital Louis Mourier - AP-HP [Colombes] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHI Poissy-Saint-Germain, Chitrit, Yvon, Benachi, Alexandra, Kayem, Gilles, CIC - CHU Bichat ; 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), Doloy, Alexandra, Goffinet, Francois, Université Paris Diderot - Paris 7 (UPD7), Hôpital Hôtel-Dieu [Paris] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Trousseau [APHP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Bebear, Cecile, CHU Saint-Antoine [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Paris Descartes - Paris 5 (UPD5), Fenollar, Florence, Poyart, Claire, Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)) ; Université Paris 13 (UP13)-Université

2018

Overview

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.Design: A randomized, double-blind, placebo-controlled trial.Setting: 10 maternal fetal medicine centers in France.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.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. Main outcome measures The primary outcome was delivery before 37 weeks.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.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.

• Publisher: CCSD,Public Library of Science,Public Library of Science (PLoS)
• Subject: Adult / Amniocentesis / Amniotic fluid / Amniotic Fluid - drug effects / Amniotic Fluid - microbiology / Analysis / Anti-Bacterial Agents - pharmacology / Antibiotics / Biology and Life Sciences / Birth / Colonization / Dosage and administration / Down's syndrome / Epidemiology / Female / Fetuses / Gestation / Gynecology / Gynecology and obstetrics / Health aspects / Human health and pathology / Humans / Infectious diseases / Inflammation / Josamycin / Life Sciences / Medicine and Health Sciences / Mycoplasma / Mycoplasma - drug effects / Mycoplasma - physiology / Mycoplasmatales / Neonates / Newborn babies / Obstetrics / Pediatrics / Polymerase chain reaction / Pregnancy / Pregnant women / Premature birth / Premature Birth - microbiology / Premature Birth - prevention & control / Prenatal diagnosis / Prevention / Research and Analysis Methods / Screening / Ureaplasma / Ureaplasma - drug effects / Ureaplasma - physiology / Womens health
• ISBN: 0004493795000