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Completed

NCT Number: NCT00718705

Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Groupe Hospitalier Chenevier-Mondor, CHI

Créteil, 94, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Josamycin

Drug

josamycin with posology of 2 grams per day by oral way during 10 days

Placebo

Drug

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

Primary outcomes

  1. Premature birth

    Time frame: between 22 and 37 completed weeks of pregnancy.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Bayer

Registry information

Official study 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

Acronym: PREMYC

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 21, 2008
Registry last updated
Dec 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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