NCT00718705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 29, 2011

Status Verified

May 1, 2011

Enrollment Period

3.2 years

First QC Date

July 17, 2008

Last Update Submit

December 27, 2011

Conditions

Prematurity

Keywords

PrematurityUreaplasma sppMycoplasma HominisAmniotic fluidJosamycine

Outcome Measures

Primary Outcomes (1)

  • Premature birth

    between 22 and 37 completed weeks of pregnancy.

Secondary Outcomes (16)

  • Antenatal :occurence of a miscarriage late

    between 16 and 22 weeks of amenorrhoea

  • Antenatal : premature delivery

    at week of amenorrhea <= 34, 32, 28

  • Antenatal : hospitalisation for risk of premature delivery

    antenatal period

  • antenatal : Number of day of hospitalisation for risk of premature delivery

    antenatal period

  • Antenatal : premature rupture of membranes

    before 37 week of amenorrhea

  • +11 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

josamycin

Drug: Josamycin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

JosamycinDRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No speaking french
  • Having an allergy to macrolides
  • Having a multiple pregnancy
  • Morphological Anomaly
  • Patient no consented
  • Lactose Intolerance
  • Not agreed to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Chenevier-Mondor, CHI

Créteil, 94, France

Location

Related Publications (2)

  • Marcellin L, Batteux F, Chouzenoux S, Schmitz T, Lorthe E, Mehats C, Goffinet F, Kayem G. Second-trimester amniotic fluid proteins changes in subsequent spontaneous preterm birth. Acta Obstet Gynecol Scand. 2023 May;102(5):597-604. doi: 10.1111/aogs.14544. Epub 2023 Mar 14.

    PMID: 36918342DERIVED

  • Kayem G, Doloy A, Schmitz T, Chitrit Y, Bouhanna P, Carbonne B, Jouannic JM, Mandelbrot L, Benachi A, Azria E, Maillard F, Fenollar F, Poyart C, Bebear C, Goffinet F. Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial. PLoS One. 2018 Nov 7;13(11):e0206290. doi: 10.1371/journal.pone.0206290. eCollection 2018.

    PMID: 30403730DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Josamycin

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Gilles KAYEM

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-05

Locations

FR(1)