The purpose of this study is to test the effectiveness of an antibiotic treatment (Josamycin) in the case of positive PCR for Ureaplasma spp. and/or Mycoplasma hominis in the second quarter on the risk of premature birth.
Infection would be the cause of 40 % of spontaneous premature deliveries. The physiopathological hypothesis accepted is a premature ascent of present bacteria in the low genital ways towards the decidual, the foetal membranes then the amniotic liquid. These bacteria are responsible for an inflammatory reaction to the interface feto-maternal characterized by the production of proinflammatory cytokines and pro-contractants agents (prostaglandins, oxytocin) by the decidual and the membranes. These mediators cause uterine contractions, a maturation of the uterine collar, a rupture of the membranes then a premature birth. Several recent publications show on the one hand that Mycoplasma hominis and Ureaplasma spp. are the bacteria most frequently found in the amniotic liquid in the second quarter of the pregnancy and that a positive PCR for these bacteria is associated with a premature birth. A probable assumption would be that Mycoplasma hominis or Ureaplasma spp. cause a premature birth by infecting the fetal membranes and the decidual, then activating the immune system and the pro-inflammatory production of cytokines. These bacteria are sensitive to antibiotic treatment. Nevertheless, no randomized controlled trials have been carried out to determine wether an antibiotic treatment would decrease spontaneous prematurity in the case of positive PCR in the amniotic liquid.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,200
Groupe Hospitalier Chenevier-Mondor, CHI
Créteil, France
Premature birth
Time frame: between 22 and 37 completed weeks of pregnancy.
Antenatal :occurence of a miscarriage late
Time frame: between 16 and 22 weeks of amenorrhoea
Antenatal : premature delivery
Time frame: at week of amenorrhea <= 34, 32, 28
Antenatal : hospitalisation for risk of premature delivery
Time frame: antenatal period
antenatal : Number of day of hospitalisation for risk of premature delivery
Time frame: antenatal period
Antenatal : premature rupture of membranes
Time frame: before 37 week of amenorrhea
Antenatal : occurence of chorioamnionitis defined by 2 of the following criteria :maternal temperature > 38°C, uterine contractions, Fetid leucorrhoeas, foetal tachycardia > 160bpm, C reactive protein >10mg/l
Time frame: antenatal period
During childbirth : Hyperthermia > 38°C
Time frame: Childbirth period
During childbirth : fetal tachycardia > 160 bpm
Time frame: childbirth period
Post-partum : Hyperthermia > 38°C for more than 24hours
Time frame: post partum period
Post partum :need an antibiotic treatment for more than 48 hours
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Time frame: post partum period
Neonatal : neonatal mortality late
Time frame: from day 7 to day 28
Neonatal : early neonatal mortality
Time frame: from day 0 to day 6
Neonatal morbidity : immediate neonatal state
Time frame: neonatal period
Neonatal morbidity : infection
Time frame: neonatal period
Neonatal morbidity : respiratory disease
Time frame: neonatal period
Neonatal morbidity : digestive disease
Time frame: neonatal period