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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00718705
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : December 29, 2011
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 risk of premature birth.

Condition or disease Intervention/treatment Phase
Prematurity Drug: Josamycin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: 1
Drug: Josamycin
josamycin with posology of 2 grams per day by oral way during 10 days

Placebo Comparator: 2
Drug: Placebo
Placebo with posology of 2 grams per day by oral way during 10 days

Primary Outcome Measures :
  1. Premature birth [ Time Frame: between 22 and 37 completed weeks of pregnancy. ]

Secondary Outcome Measures :
  1. Antenatal :occurence of a miscarriage late [ Time Frame: between 16 and 22 weeks of amenorrhoea ]
  2. Antenatal : premature delivery [ Time Frame: at week of amenorrhea <= 34, 32, 28 ]
  3. Antenatal : hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
  4. antenatal : Number of day of hospitalisation for risk of premature delivery [ Time Frame: antenatal period ]
  5. Antenatal : premature rupture of membranes [ Time Frame: before 37 week of amenorrhea ]
  6. 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 ]
  7. During childbirth : Hyperthermia > 38°C [ Time Frame: Childbirth period ]
  8. During childbirth : fetal tachycardia > 160 bpm [ Time Frame: childbirth period ]
  9. Post-partum : Hyperthermia > 38°C for more than 24hours [ Time Frame: post partum period ]
  10. Post partum :need an antibiotic treatment for more than 48 hours [ Time Frame: post partum period ]
  11. Neonatal : neonatal mortality late [ Time Frame: from day 7 to day 28 ]
  12. Neonatal : early neonatal mortality [ Time Frame: from day 0 to day 6 ]
  13. Neonatal morbidity : immediate neonatal state [ Time Frame: neonatal period ]
  14. Neonatal morbidity : infection [ Time Frame: neonatal period ]
  15. Neonatal morbidity : respiratory disease [ Time Frame: neonatal period ]
  16. Neonatal morbidity : digestive disease [ Time Frame: neonatal period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00718705

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Groupe Hospitalier Chenevier-Mondor, CHI
Creteil, France, 94
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Gilles KAYEM Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00718705    
Other Study ID Numbers: P060216
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: May 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Ureaplasma spp
Mycoplasma Hominis
Amniotic fluid
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Bacterial Agents
Anti-Infective Agents