Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Bayer
• Treatments: Anti-Bacterial Agents; Josamycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• No speaking french

• Having an allergy to macrolides

• Having a multiple pregnancy

• Morphological Anomaly

• Patient no consented

• Lactose Intolerance

• Not agreed to participate