Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)
NCT ID: NCT00718705
Last Updated: 2011-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3200 participants
INTERVENTIONAL
2008-07-31
2011-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
josamycin
Josamycin
josamycin with posology of 2 grams per day by oral way during 10 days
2
Placebo
Placebo
Placebo with posology of 2 grams per day by oral way during 10 days
Interventions
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Josamycin
josamycin with posology of 2 grams per day by oral way during 10 days
Placebo
Placebo with posology of 2 grams per day by oral way during 10 days
Eligibility Criteria
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Inclusion Criteria
* French speaking
* Women who have an amniocentesis between 15 and 20 weeks of amenorrhoea for an antenatal diagnosis
* Affiliated to social security or an equivalent system
* Karyotype analysis and ultrasound morphological normal (apart from minor signs of trisomy 21)
* Clear amniotic fluid (not contaminated by the mother's blood)
* Gestational age is between 15 WA(day+0) and 20 WA(day+6)
* Patient have not allergy to macrolides
* Do not have cure underway by macrolide
* Patient followed during her pregnancy in an investigator site
* Informed consent and signed
Exclusion Criteria
* Having an allergy to macrolides
* Having a multiple pregnancy
* Morphological Anomaly
* Patient no consented
* Lactose Intolerance
* Not agreed to participate
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Gilles KAYEM
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Groupe Hospitalier Chenevier-Mondor, CHI
Créteil, , France
Countries
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References
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Marcellin L, Batteux F, Chouzenoux S, Schmitz T, Lorthe E, Mehats C, Goffinet F, Kayem G. Second-trimester amniotic fluid proteins changes in subsequent spontaneous preterm birth. Acta Obstet Gynecol Scand. 2023 May;102(5):597-604. doi: 10.1111/aogs.14544. Epub 2023 Mar 14.
Kayem G, Doloy A, Schmitz T, Chitrit Y, Bouhanna P, Carbonne B, Jouannic JM, Mandelbrot L, Benachi A, Azria E, Maillard F, Fenollar F, Poyart C, Bebear C, Goffinet F. Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial. PLoS One. 2018 Nov 7;13(11):e0206290. doi: 10.1371/journal.pone.0206290. eCollection 2018.
Other Identifiers
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P060216
Identifier Type: -
Identifier Source: org_study_id