Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

Prematurity Clinical Trial

— PREMYC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718705
• Other study ID #: P060216
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2008
• Last updated: December 27, 2011
• Start date: July 2008
• Est. completion date: September 2011

Study information

• Verified date: May 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3200
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

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

Locations

Country	Name	City	State
France	Groupe Hospitalier Chenevier-Mondor, CHI	Creteil

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature birth		between 22 and 37 completed weeks of pregnancy.	Yes
Secondary	Antenatal :occurence of a miscarriage late		between 16 and 22 weeks of amenorrhoea	Yes
Secondary	Antenatal : premature delivery		at week of amenorrhea <= 34, 32, 28	Yes
Secondary	Antenatal : hospitalisation for risk of premature delivery		antenatal period	Yes
Secondary	antenatal : Number of day of hospitalisation for risk of premature delivery		antenatal period	Yes
Secondary	Antenatal : premature rupture of membranes		before 37 week of amenorrhea	Yes
Secondary	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		antenatal period	Yes
Secondary	During childbirth : Hyperthermia > 38°C		Childbirth period	Yes
Secondary	During childbirth : fetal tachycardia > 160 bpm		childbirth period	Yes
Secondary	Post-partum : Hyperthermia > 38°C for more than 24hours		post partum period	Yes
Secondary	Post partum :need an antibiotic treatment for more than 48 hours		post partum period	Yes
Secondary	Neonatal : neonatal mortality late		from day 7 to day 28	Yes
Secondary	Neonatal : early neonatal mortality		from day 0 to day 6	Yes
Secondary	Neonatal morbidity : immediate neonatal state		neonatal period	Yes
Secondary	Neonatal morbidity : infection		neonatal period	Yes
Secondary	Neonatal morbidity : respiratory disease		neonatal period	Yes
Secondary	Neonatal morbidity : digestive disease		neonatal period	Yes