A Phase 3 interventional study of Vaginal flora abnormalities screening and quantification using molecular biology technique and Azithromycin in Bacterial Vaginosis, Vaginal Dysbiosis and Premature Delivery, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 3, Interventional, and Treatment
Preterm birth is a major cause of mortality and long-term disability. Bacterial vaginosis (BV) is a frequent form of dysbiosis that is often asymptomatic and increases the risk of preterm birth. BV is usually diagnosed using conventional tools such as the Nugent score. Molecular diagnosis of BV has now been shown to be more reproducible and to provide a more accurate characterization of dysbiosis.
The main objective of this study is to evaluate the effectiveness of a self screen and treat strategy for vaginal flora dysbiosis, based on molecular point of care (POC) multiplex technology before 18 weeks' gestation, in reducing the rate of preterm birth among pregnant women at high risk, compared with usual care.
The hypothesis is that a Screen-and-Treat strategy using molecular biology among women with previous preterm or/and an history of late abortion could be effective in reducing preterm births by 40%.
Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has now been demonstrated to be more reproducible, accurate and to better define dysbiosis.
AUTOP was a large randomized multicentre trial to evaluate a "Screen and Treat" strategy for bacterial vaginosis using molecular diagnosis of self-collected vaginal samples in low-risk pregnant women during early pregnancy, with an evaluation of treatment success, and including vaginal swab controls.
Among 6,671 randomized women, the Intent to treat analysis of the primary clinical outcome showed no evidence of a reduction in the rate of preterm birth with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.9% (events=127) among 3,333 women in the screen and treat strategy group and 4.6% (events=153) among 3,338 in the control group (aOR, 0.82 [95%CI, 0.65 to 1.05]; P=.12). In the subgroup of nulliparous women (n=3,438), Screening and treating strategy was significantly more effective than usual care (aOR 0.61, 95% CI 0.44 to 0.82; Pinteraction=0.001).
AUTOP I has been submit to JAMA at the beginning of 2023. AUTOP was the first randomized study that evaluates the impact of Screen and Treat strategies using molecular biology during pregnancy, except one ongoing study.
The main objective of AUTOP 2 is to evaluate the effectiveness of a self screen and treat strategy for vaginal flora dysbiosis, based on molecular point of care (POC) multiplex technology before 18 weeks' gestation, in reducing the rate of preterm birth among pregnant women at high risk, compared with usual care.
AUTOP 2 is a multicenter, prospective, randomized and parallel, open-label comparative, phase 3 study comparing 2 groups of pregnancy management in a population of pregnant women at high risk of preterm birth:
The recruitment goal is of 1794 women (897 per group).The period of inclusion has been scheduled to be 24 months s. Each woman will be followed until her newborn is discharged from the hospital, for a maximum of 4 months after delivery. Therefore, the maximum participation period is 12 months.
A reduction in prematurity and/or late abortions in the group screening and treatment of vaginal flora abnormalities is expected. This strategy could be implemented routinely if the results were significant.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's planned enrollment of 1,794 is above the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 140 are open to participants now.
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With a history of :
Any eligible woman who will agree to participate in the study after being invited must sign a consent form before being included in the study. Women meeting all of these eligibility criteria will be invited even if they have oral or vaginal progestative treatment, cerclage or pessary, partially septate or arcuate uterus.
Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients systematically screened for BV before 18 weeks' gestation by means of a vaginal swab analyzed by the innovative technique by PCR, whose result will be disclosed. If positive, appropriate treatment will be prescribed.
Diagnostic Test: Vaginal flora abnormalities screening and quantification using molecular biology technique · Drug: Azithromycin · Drug: Ceftriaxone · Drug: Metronidazole · Drug: Clotrimazole · Drug: Doxycyclin
Usual care group with no screening with multiplex molecular biology. Women will be screened for BV with conventional tools (pH, Amsel or Nugent score) as recommended by ANAES. Woman under 25 years old or/and at risk of sexual transmitted infection: screening for Chlamydia trachomatis will be done as recommended by HAS.
Vaginal self-sampling is a simple and validated method of sampling used for the molecular biology technique and the quantification of microorganisms involved in vaginal flora imbalance bacteriosis.The patient performs a self-sampling with a cotton swab transferred into a transport medium tube. The sample is sent to the laboratory where Multiplex Point of Care polymerase chain reaction (PCR) is performed.
In case of Chlamydia trachomatis infections: Azithromycin 1 g per os during the second and third trimester of pregnancy .
In case of Neisseria gonorrhoeae infections: Ceftriaxone 1 g IM as a single dose.
In case of Trichomonas vaginalis infections: Metronidazole 500 mg 2 times/day for 7 days, whatever the trimester of pregnancy is . In case of Gardnerella vaginalis infection: Metronidazole 500 mg orally 2 times/day for 7 days . In case of Atopobium/Fannyhessea vaginae and/or Gardnerella vaginalis positivity: Metronidazole 500 mg orally 2 times/day for 7 days .
In case of Candida albicans infection: 500 mg in a single dose. If necessary, this treatment could be repeated up to 6 times .
During first trimester of pregnancy ,in case of Chlamydia trachomatis infections at a dose of 200 mg/day 7 days .
The rate of preterm birth
The primary endpoint will be the rate of preterm birth before 37 weeks of gestation, which will be compared between the innovative group (Group A experimental) and the standard group (Group B Usual care).
Time frame: From the enrollment to the delivery date
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2029, 32 months later.
Of 12 phase 3 interventional studies under Vaginosis, Bacterial, half reached primary completion within 9 months of starting (the median); a quarter within 5 and three quarters within 25. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Azithromycin · Ceftriaxone · Metronidazole · Clotrimazole · Doxycycline
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