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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00718705
First received: July 17, 2008
Last updated: December 27, 2011
Last verified: May 2011
  Purpose
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 Intervention Phase
Prematurity
Drug: Josamycin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3200
Study Start Date: July 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
josamycin
Drug: Josamycin
josamycin with posology of 2 grams per day by oral way during 10 days
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo with posology of 2 grams per day by oral way during 10 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718705

Locations
France
Groupe Hospitalier Chenevier-Mondor, CHI
Creteil, France, 94
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Bayer
Investigators
Principal Investigator: Gilles KAYEM Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00718705     History of Changes
Other Study ID Numbers: P060216
Study First Received: July 17, 2008
Last Updated: December 27, 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prematurity
Ureaplasma spp
Mycoplasma Hominis
Amniotic fluid
Josamycine

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Bacterial Agents
Josamycin
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 24, 2017