Groupe Hospitalier Chenevier-Mondor, CHI
Créteil, 94, France
NCT Number: NCT00718705
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.
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Notify Me18 year and older
Female
Interventional
Phase 3
Créteil, 94, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
josamycin with posology of 2 grams per day by oral way during 10 days
Placebo with posology of 2 grams per day by oral way during 10 days
Time frame: between 22 and 37 completed weeks of pregnancy.
Time frame: between 16 and 22 weeks of amenorrhoea
Time frame: at week of amenorrhea <= 34, 32, 28
Time frame: antenatal period
Time frame: antenatal period
Time frame: before 37 week of amenorrhea
Time frame: antenatal period
Time frame: Childbirth period
Time frame: childbirth period
Time frame: post partum period
Time frame: post partum period
Time frame: from day 7 to day 28
Time frame: from day 0 to day 6
Time frame: neonatal period
Time frame: neonatal period
Time frame: neonatal period
Time frame: neonatal period
Assistance Publique - Hôpitaux de Paris
Other
Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid
Acronym: PREMYC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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