NCT00718705

Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,200 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prematurity

Interventions

Type	Name	Description
DRUG	Josamycin	josamycin with posology of 2 grams per day by oral way during 10 days
DRUG	Placebo	Placebo with posology of 2 grams per day by oral way during 10 days

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-07-21
• Last updated: 2011-12-29

Locations

1 site across 1 country: France