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

NCT02288832 | Completed Phase 2 DMC

• 2 other identifiers: 2014-001559-22RCAPHM14_0085
• Study Type: interventional
• Target: 6,800
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Risk of Preterm Delivery

Outcome Measures

Primary Outcomes (1)

• the incremental cost-effectiveness

  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);

  30 months

Secondary Outcomes (6)

• 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

  30 months

• the rate of endometritis

  30 months

• the preterm birth rate adjusted

  30 months

Study Arms (2)

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.

Other: -self-collected vaginal samples; Drug: zithromax

Standard strategy (group B):

OTHER

This group will be followed according to the usual practices of the physicians seeing them.

Other: usual practices

Interventions

-self-collected vaginal samples OTHER

Innovative strategy (group A):

zithromax DRUG

Also known as: azithromycine

Innovative strategy (group A):

usual practices OTHER

Standard strategy (group B):

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Woman withdrawing her consent during the study

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (2)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Hôpital Nord Assistance Publique Hôpitaux de Marseille

Marseille, 13915, France

Location

Related Publications (2)

• 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.

  PMID: 37459059 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.

  PMID: 26482128 DERIVED

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Urielle DESALBRES

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 11, 2014
• Study Start: March 6, 2015
• Primary Completion: July 1, 2018
• Study Completion: October 21, 2022
• Last Updated: April 13, 2023

Record last verified: 2015-11

Locations

FR (2)