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Low Risk of Preterm DeliveryPhase 2/3AuTopNCT02288832

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

A Phase 2/3 study testing -self-collected vaginal samples, zithromax and usual practices in people with Low Risk of Preterm Delivery, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Low Risk of Preterm Delivery
What is being tested?
-self-collected vaginal samples, zithromax and usual practices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,800 participants
Where
2 sitesFrance
Study dates
6 Mar 2015to 21 Oct 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Woman withdrawing her consent during the study

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Assistance Publique Hopitaux de Marseille

    Marseille, 13354

  • Hôpital Nord Assistance Publique Hôpitaux de Marseille

    Marseille, 13915

Other trials in France

About this study

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.

Read the 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.

Being tested
-self-collected vaginal samples, zithromax, usual practices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • -self-collected vaginal samplesOther

  • zithromaxDrug

    Also called azithromycine

  • usual practicesOther

Study groups in NCT02288832
Study groupRoleWhat they receive
Innovative strategy (group A):Experimentalthese 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.
Receives: Other: -self-collected vaginal samples; Drug: zithromax
Standard strategy (group B):OtherThis group will be followed according to the usual practices of the physicians seeing them.
Receives: Other: usual practices

What is being measured

The primary outcome is the main question the study is designed to answer.

  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);

    Measured: 30 months

Secondary outcomes (6)

  1. the delivery rate before 26, 28, 32 and 37 weeks

    Measured: 30 months

  2. the rate of rupture of membranes

    Measured: 30 months

  3. the rate of intrauterine growth retardation

    Measured: 30 months

  4. the rate of endometritis

    Measured: 30 months

  5. the preterm birth rate adjusted

    Measured: 30 months

  6. he total duration of hospitalization and earlier for postpartum mother and newborn in number of days

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2014 (estimated)
  2. Study start6 Mar 2015
  3. Primary completion1 Jul 2018
  4. Study completion21 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02288832
Sponsor's protocol ID
2014-001559-22
Other IDs
RCAPHM14_0085, 2014
Acronym
AuTop
Status last verified
Nov 2015
First submitted
30 Oct 2014
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 42252439

  • 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.

    PubMed 37459059

  • 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.

    PubMed 26482128

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing -self-collected vaginal samples, zithromax and usual practices in people with Low Risk of Preterm Delivery, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incremental cost-effectiveness (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02288832, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

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