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| ID | Type | Description | Link |
|---|---|---|---|
| RCAPHM14_0085 | Other Identifier | AP HM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Innovative strategy (group A): | Experimental | 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. |
|
| Standard strategy (group B): | Other | This group will be followed according to the usual practices of the physicians seeing them. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| -self-collected vaginal samples | Other |
| ||
| zithromax |
| Measure | Description | Time Frame |
|---|---|---|
| the incremental cost-effectiveness | the incremental cost-effectiveness ratio between the two groups corresponding to the cost of preterm birth before 37 avoided.
| 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| the delivery rate before 26, 28, 32 and 37 weeks | 30 months | |
| the rate of rupture of membranes | 30 months | |
| the rate of intrauterine growth retardation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urielle DESALBRES | Assistance Publique Hopitaux De Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | 13354 | France | |||
| Hôpital Nord Assistance Publique Hôpitaux de Marseille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42252439 | Derived | Loubiere S, Loundou A, Cocallemen JF, Fenollar F, Bretelle F. Cost-effectiveness of a real-time screening strategy for bacterial vaginosis using qPCR to prevent preterm birth: results from a randomized prospective multicenter study. Cost Eff Resour Alloc. 2026 Jun 8. doi: 10.1186/s12962-026-00780-7. Online ahead of print. | |
| 37459059 |
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| Drug |
|
|
| usual practices | Other |
|
| 30 months |
| the rate of endometritis | 30 months |
| the preterm birth rate adjusted | 30 months |
| he total duration of hospitalization and earlier for postpartum mother and newborn in number of days | 30 months |
| Marseille |
| 13915 |
| France |
| Bretelle F, Loubiere S, Desbriere R, Loundou A, Blanc J, Heckenroth H, Schmitz T, Benachi A, Haddad B, Mauviel F, Danoy X, Mares P, Chenni N, Menard JP, Cocallemen JF, Slim N, Senat MV, Chauleur C, Bohec C, Kayem G, Trastour C, Bongain A, Rozenberg P, Serazin V, Fenollar F; Groupe de Recherche en Obstetrique et Gynecologie (GROG) Investigators. Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial. JAMA Pediatr. 2023 Sep 1;177(9):894-902. doi: 10.1001/jamapediatrics.2023.2250. |
| 26482128 | Derived | Bretelle F, Fenollar F, Baumstarck K, Fortanier C, Cocallemen JF, Serazin V, Raoult D, Auquier P, Loubiere 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. |
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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