Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin) (PREMYC)
|ClinicalTrials.gov Identifier: NCT00718705|
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : December 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Prematurity||Drug: Josamycin Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
josamycin with posology of 2 grams per day by oral way during 10 days
Placebo Comparator: 2
Placebo with posology of 2 grams per day by oral way during 10 days
- Premature birth [ Time Frame: between 22 and 37 completed weeks of pregnancy. ]
- Antenatal :occurence of a miscarriage late [ Time Frame: between 16 and 22 weeks of amenorrhoea ]
- Antenatal : premature delivery [ Time Frame: at week of amenorrhea <= 34, 32, 28 ]
- Antenatal : hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
- antenatal : Number of day of hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
- Antenatal : premature rupture of membranes [ Time Frame: before 37 week of amenorrhea ]
- Antenatal : occurence of chorioamnionitis defined by 2 of the following criteria :maternal temperature > 38°C, uterine contractions, Fetid leucorrhoeas, foetal tachycardia > 160bpm, C reactive protein >10mg/l [ Time Frame: antenatal period ]
- During childbirth : Hyperthermia > 38°C [ Time Frame: Childbirth period ]
- During childbirth : fetal tachycardia > 160 bpm [ Time Frame: childbirth period ]
- Post-partum : Hyperthermia > 38°C for more than 24hours [ Time Frame: post partum period ]
- Post partum :need an antibiotic treatment for more than 48 hours [ Time Frame: post partum period ]
- Neonatal : neonatal mortality late [ Time Frame: from day 7 to day 28 ]
- Neonatal : early neonatal mortality [ Time Frame: from day 0 to day 6 ]
- Neonatal morbidity : immediate neonatal state [ Time Frame: neonatal period ]
- Neonatal morbidity : infection [ Time Frame: neonatal period ]
- Neonatal morbidity : respiratory disease [ Time Frame: neonatal period ]
- Neonatal morbidity : digestive disease [ Time Frame: neonatal period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718705
|Groupe Hospitalier Chenevier-Mondor, CHI|
|Creteil, France, 94|
|Principal Investigator:||Gilles KAYEM||Assistance Publique - Hôpitaux de Paris|