Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06349122 |
Other study ID # |
2023-509421-41-00 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
August 2024 |
Est. completion date |
January 2028 |
Study information
Verified date |
March 2024 |
Source |
Assistance Publique Hopitaux De Marseille |
Contact |
Franceline CARTIER |
Phone |
+33491381927 |
Email |
promotion.interne[@]ap-hm.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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 been demonstrated to be more reproducible, more accurate and to better define dysbiosis.
The main objective of the study is to evaluate the effectiveness of an innovative
screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point
of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth
in a population of pregnant women at high risk of preterm birth.
The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and
their recurrences using molecular biology in women with a history of prematurity or late-term
abortion could be effective in reducing premature births by 40%.
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 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 study is to evaluate the effectiveness of an innovative
screen-and-treat strategy for vaginal flora abnormalities by molecular biology using Point of
Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a
population of pregnant women at high risk of preterm birth (with previous history of preterm
birth or late fetal loss) , in comparison with a standard strategy with absence of screening.
AUTOP 2 is a multicenter, prospective, randomized, parallel, open-label comparative study
comparing 2 groups of pregnancy management in a population of pregnant women at high risk of
preterm birth.
- Screen-and-Treat Innovative Strategy (Group A): patients systematically screened for BV
before 18 weeks of gestation by means of a vaginal swab analyzed by the innovative
technique, whose result will be disclosed. If positive, appropriate treatment will be
prescribed.
- Control Group/Usual Care or Standard Strategy (Group B): patients not systematically
screened for BV/usual care group.
The recruitment goal is of 1292 women (646 per group). The period of inclusion has been
scheduled to be 24 months. Each subject will be followed for a period of 17 months (maximum 7
months of pregnancy until term and 10 months post-delivery).
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.