Trial reportPloS one2018
Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial.
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00718705 (Reduction of Spontaneous Prematurity), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Maternal Ureaplasma exposure during pregnancy and the risk of preterm birth and BPD: a meta-analysis.Archives of gynecology and obstetrics · 2022Pooled it
- Second-trimester amniotic fluid proteins changes in subsequent spontaneous preterm birth.Acta obstetricia et gynecologica Scandinavica · 2023Trial
- Clinical Manifestations and Associated Disease States withOpen forum infectious diseases · 2026Article
- A 19-Year Audit of Genital Mycoplasma Species in Blood Cultures From Women Attending a Tertiary Maternity Hospital.The Australian & New Zealand journal of obstetrics & gynaecology · 2026Article
- Treatment Effects of Genital Mycoplasma Species in High-Risk Pregnant Individuals: A Retrospective Cohort Study.Cureus · 2025Article
- Detection ofFrontiers in cellular and infection microbiology · 2025Article
- Prevalence of genital Mycoplasma in pregnancies with shortened cervix.Archives of gynecology and obstetrics · 2024Article
- Does vaginal bacterial colonization contribute to preterm birth in women with asymptomatic shortened cervix?Archives of gynecology and obstetrics · 2024Article
- Nanopore-based metagenomics analysis reveals microbial presence in amniotic fluid: A prospective study.Heliyon · 2024Article
- Characterisation of Mid-Gestation Amniotic Fluid Cytokine and Bacterial DNA Profiles in Relation to Pregnancy Outcome in a Small Australian Cohort.Microorganisms · 2023Article
- Beyond the Gut, Emerging Microbiome Areas of Research: A Focus on Early-Life Microbial Colonization.Microorganisms · 2023Review
- Review
- Antibiotic prophylaxis in preterm premature rupture of membranes at 24-31 weeks' gestation: Perinatal and 2-year outcomes in the EPIPAGE-2 cohort.BJOG : an international journal of obstetrics and gynaecology · 2022Article
- Weighing Potential Benefits and Harms of Mycoplasma genitalium Testing and Treatment Approaches.Emerging infectious diseases · 2022Article
- Article
- Comparison of Bacterial DNA Profiles in Mid-Trimester Amniotic Fluid Samples From Preterm and Term Deliveries.Frontiers in microbiology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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.
designA randomized, double-blind, placebo-controlled trial.
setting10 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.
methodsAmniotic 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 measuresThe primary outcome was delivery before 37 weeks.
resultsIn 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.
conclusionsBecause 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.
trial registrationClinicalTrials.gov NCT00718705.
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