Status:
COMPLETED
Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Bayer
Conditions:
Prematurity
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 ris...
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 decid...
Eligibility Criteria
Inclusion
- Patient older ≥ 18 years
- 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
- No speaking french
- Having an allergy to macrolides
- Having a multiple pregnancy
- Morphological Anomaly
- Patient no consented
- Lactose Intolerance
- Not agreed to participate
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT00718705
Start Date
July 1 2008
End Date
September 1 2011
Last Update
December 29 2011
Active Locations (1)
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1
Groupe Hospitalier Chenevier-Mondor, CHI
Créteil, France, 94