Bacterial VaginosisPhase 3AUTOP 2NCT06349122
AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth
A Phase 3 study testing Vaginal flora abnormalities screening and quantification using molecular biology technique, Azithromycin and Ceftriaxone in people with Bacterial Vaginosis and Vaginal Dysbiosis, run by Assistance Publique Hopitaux De Marseille.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Vaginal Dysbiosis, Premature Delivery
- What is being tested?
- Vaginal flora abnormalities screening and quantification using molecular biology technique, Azithromycin and Ceftriaxone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,794 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2029
- Phase
- Phase 3
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
None listed.
Who cannot join
- - Woman of legal age under legal protection;
- Women deprived of their freedom for administrative or legal reasons;
- Woman who has not signed a consent form
- Nulliparous;
- Ectopic pregnancy;
- Non-evolutive pregnancy or IUFD
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- Multiple pregnancy
- Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, diaphragmatic hernia, cerebral or spinal major anomaly.
- Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study
- Woman presenting contraindications to the study treatments: Hypersensitivity to the active substance or to any of the excipients
- Woman presenting uterine malformation ( unicornuate, bicornuate, full septate)
- Woman with preterm birth history because of twin pregnancy
- Woman having received anti-infective treatment in the week preceding inclusion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP 2)
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%.
Read the detailed description
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 experimental group (group A) with self vaginal screening with molecular multiplex biology.
- The usual care group (group B) 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. Women under 25 years of age who are sexually active and/or at risk for sexually transmitted infections will be screened for Chlamydia trachomatis, as recommended by HAS.
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.
- Conditions
- Bacterial Vaginosis, Vaginal Dysbiosis, Premature Delivery
- Being tested
- Vaginal flora abnormalities screening and quantification using molecular biology technique, Azithromycin, Ceftriaxone, Metronidazole, Clotrimazole
- Keywords
- screen and treat strategy
- Medical subject headings
- Vaginosis, Bacterial, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal flora abnormalities screening and quantification using molecular biology techniqueDiagnostic test
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.
AzithromycinDrug
In case of Chlamydia trachomatis infections: Azithromycin 1 g per os during the second and third trimester of pregnancy .
CeftriaxoneDrug
In case of Neisseria gonorrhoeae infections: Ceftriaxone 1 g IM as a single dose.
MetronidazoleDrug
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 .
ClotrimazoleDrug
In case of Candida albicans infection: 500 mg in a single dose. If necessary, this treatment could be repeated up to 6 times .
DoxycyclinDrug
During first trimester of pregnancy ,in case of Chlamydia trachomatis infections at a dose of 200 mg/day 7 days .
| Study group | Role | What they receive |
|---|---|---|
| Group A: Screen-and-Treat Strategy | Experimental | 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. Receives: Diagnostic Test: Vaginal flora abnormalities screening and quantification using molecular biology technique; Drug: Azithromycin; Drug: Ceftriaxone; Drug: Metronidazole; Drug: Clotrimazole; Drug: Doxycyclin |
| Group B: Control Group/Usual Care or Standard Strategy | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the enrollment to the delivery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,794 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349122
- Sponsor's protocol ID
- 2023-509421-41-03
- Other IDs
- 2023
- Acronym
- AUTOP 2
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No