Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349122
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-14
Brief Title:
Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Screen-and-treat Strategy for Vaginal Flora Abnormalities by Multiplex Molecular Biology Using POC Technology in Pregnant Women at High Risk of Preterm Birth A Multicentre Randomized Study AUTOP2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUTOP2
Brief 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
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
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 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 6671 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 39 events127 among 3333 women in the screen and treat strategy group and 46 events153 among 3338 in the control group aOR 082 95CI 065 to 105 P12 In the subgroup of nulliparous women n3438 Screening and treating strategy was significantly more effective than usual care aOR 061 95 CI 044 to 082 Pinteraction0001
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 GroupUsual Care or Standard Strategy Group B patients not systematically screened for BVusual 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 andor 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
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 6671 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 39 events127 among 3333 women in the screen and treat strategy group and 46 events153 among 3338 in the control group aOR 082 95CI 065 to 105 P12 In the subgroup of nulliparous women n3438 Screening and treating strategy was significantly more effective than usual care aOR 061 95 CI 044 to 082 Pinteraction0001
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 GroupUsual Care or Standard Strategy Group B patients not systematically screened for BVusual 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None