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Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy (AuTop)

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ClinicalTrials.gov Identifier: NCT02288832
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE October 30, 2014
First Posted Date  ICMJE November 11, 2014
Last Update Posted Date September 3, 2018
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2014)
the incremental cost-effectiveness [ Time Frame: 30 months ]
the incremental cost-effectiveness ratio between the two groups corresponding to the cost of preterm birth before 37 avoided.
  • average differential effect in terms of preterm birth before 37 weeks of 0.013. A preterm birth rate of 0.043 (+/- 0.043) is expected in the group B and 0.03 (+/- 0.03) in Group A;
  • Cost differential means € 230 +/- 35. This difference takes into account the estimated EFC (initial and recurrent) cost and estimated cost of treatments vaginosis cases (10% of patients);
  • Cost-effectiveness threshold of 22,500 euros corresponding to the average cost ratio that is could avoid caring for a child born prematurely before 37 weeks as documented in the international literature (Petrou 2012);
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02288832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2014)
  • the delivery rate before 26, 28, 32 and 37 weeks [ Time Frame: 30 months ]
  • the rate of rupture of membranes [ Time Frame: 30 months ]
  • the rate of intrauterine growth retardation [ Time Frame: 30 months ]
  • the rate of endometritis [ Time Frame: 30 months ]
  • the preterm birth rate adjusted [ Time Frame: 30 months ]
  • he total duration of hospitalization and earlier for postpartum mother and newborn in number of days [ Time Frame: 30 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy
Official Title  ICMJE Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy
Brief Summary

Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries have no abnormal history. It is widely agreed that preterm delivery is often associated with bacterial vaginosis. One of the major difficulties at this time is that the diagnosis of bacterial vaginosis is based on heterogeneous criteria. The technique currently used is the Nugent score, but it lacks the characteristics necessary for widespread use in the general population. It must be performed on a fresh swab, and any delay in transporting it can cause drying that makes the test difficult to perform.

The investigators have developed a rapid diagnostic tool for bacterial vaginosis using molecular biology based on a point of care model and obtained a patent (European Patent Office N° 2087134). In comparison with the reference techniques, our tool's performance has been excellent, in terms of specificity, sensitivity, and positive and negative predictive values. In particular, our work showed that 57% of the flora samples rated as intermediate on the Nugent score were in reality true bacterial vaginosis. Molecular biology therefore identifies a homogeneous population of women with vaginal flora anomalies. The investigators recently showed that the carriage of Atopobium vaginae and/or Gardnerella vaginalis >105/mL shortens the time to delivery in a population at risk of preterm delivery (PHRC 2006). Vaginal flora anomalies are therefore an important target for preventing preterm delivery.

Detailed Description The principal objective is to use a cost-effectiveness study to assess the medical and economic impact of a new strategy for the screening and subsequent treatment of vaginal flora anomalies before the 20th week of gestation- molecular biology techniques (PCR for A. vaginae and G. vaginalis by point-of-care testing) will test self-collected vaginal samples in a population of pregnant women at low risk of preterm delivery. There are multiple secondary objectives, including assessment of the effect of the strategy on the following indicators- delivery before 26, 32, and 37 weeks. Methods-An open-label prospective randomized study will compare 2 groups with different management of their pregnancies. Pregnant women at low risk, regardless of any symptoms, will be randomized into 2 groups. The study will not include women at high risk of preterm delivery. Innovative strategy (group A)- these women will undergo routine screening for bacterial vaginosis by analysis of their self-collected vaginal samples with this innovative technique.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Low Risk of Preterm Delivery
Intervention  ICMJE
  • Other: -self-collected vaginal samples
  • Drug: zithromax
    Other Name: azithromycine
  • Other: usual practices
Study Arms  ICMJE
  • Experimental: Innovative strategy (group A):
    these women will undergo routine screening for bacterial vaginosis by analysis of their self-collected vaginal samples with this innovative technique; if the test is found to be positive, an appropriate treatment will be prescribed. The POC (point-of-care) test will be considered positive if: A. vaginae is detected at a threshold > 105.copies per ml and/or G. vaginalis > 105 copies per ml. The women with vaginosis will be screened monthly for recurrences through 28 weeks, and recurrence will be treated.
    Interventions:
    • Other: -self-collected vaginal samples
    • Drug: zithromax
  • Standard strategy (group B):
    This group will be followed according to the usual practices of the physicians seeing them.
    Intervention: Other: usual practices
Publications * Bretelle F, Fenollar F, Baumstarck K, Fortanier C, Cocallemen JF, Serazin V, Raoult D, Auquier P, Loubière S. Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial. Trials. 2015 Oct 19;16:470. doi: 10.1186/s13063-015-1000-y. Erratum in: Trials. 2016;17:83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2014)
6800
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 12, 2018
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women over 18 years with a pregnancy before 20 weeks are some parity and gravidity;
  • Woman who understood the process and the objectives of the study and who agreed to sign an informed consent;
  • Without a history of premature birth or late abortion (population at low risk of preterm birth);
  • Having no major risk factors for prematurity: insulin-dependent diabetes, systemic lupus erythematosus, hypertension, uterine malformation, cone biopsy, multiple pregnancy;
  • No pre-existing hypertension;
  • Asymptomatic or symptomatic regarding the diagnosis of bacterial vaginosis.

Exclusion Criteria:

  • Woman withdrawing her consent during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02288832
Other Study ID Numbers  ICMJE 2014-001559-22
RCAPHM14_0085 ( Other Identifier: AP HM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Urielle DESALBRES Assistance Publique Hopitaux De Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP