Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin) (PREMYC)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Prematurity

Treatments

Drug: Placebo

Drug: Josamycin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00718705

P060216

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,200 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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