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
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.
|Condition or disease||Intervention/treatment||Phase|
|Low Risk of Preterm Delivery||Other: -self-collected vaginal samples Drug: zithromax Other: usual practices||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||July 12, 2018|
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.
Other: -self-collected vaginal samples
Other Name: azithromycine
Standard strategy (group B):
This group will be followed according to the usual practices of the physicians seeing them.
Other: usual practices
- 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);
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288832
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Hôpital Nord Assistance Publique Hôpitaux de Marseille|
|Marseille, France, 13915|
|Study Director:||Urielle DESALBRES||Assistance Publique Hopitaux De Marseille|