Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth

NCT06349122 | Not Yet Recruiting Phase 4

• 1 other identifier: 2023-509421-41-00
• Study Type: interventional
• Target: 1,292
• Locations: 0 countries
• Sites: N/A

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%.

Conditions

Bacterial Vaginosis; Vaginal Dysbiosis; Premature Delivery

Keywords

screen and treat strategy

Outcome Measures

Primary Outcomes (1)

• 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 and the standard group.

  Before 37 weeks of gestation

Study Arms (2)

Group A: Screen-and-Treat Strategy

EXPERIMENTAL

Patients are systematically screened for BV before 18 weeks' gestation by means of a vaginal swab analyzed by the innovative technique, 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: Azithromycine; Drug: Ceftriaxone; Drug: Metronidazole; Drug: Clotrimazole, Vaginal

Group B: Control Group/Usual Care or Standard Strategy

ACTIVE COMPARATOR

Patients are not systematically screened for BV /usual care group.

Other: Usual Care

Interventions

Vaginal flora abnormalities screening and quantification using molecular biology technique DIAGNOSTIC_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.

Group A: Screen-and-Treat Strategy

Azithromycine DRUG

In case of Chlamydia trachomatis infections, as well as significant increase of Fannyhessea vaginae: 1 g per os in a single dose; In case of Neisseria gonorrhoeae infection: 2 g per os in a single dose (associated to ceftriaxone 1g IM)

Group A: Screen-and-Treat Strategy

Ceftriaxone DRUG

In case of Neisseria gonorrhoeae infections, 1g, associated to azithromycin 2 g per os in a single dose

Group A: Screen-and-Treat Strategy

Metronidazole DRUG

Metronidazole ovules: In case of Trichomonas vaginalis infection during the 1st trimester of pregnancy: 1 ovule morning and evening for 14 days (French Society of Dermatology Recommendations 2016); Metronidazole 500 mg tablets in case of Trichomonas vaginalis infection during the 2nd or the 3rd trimester of pregnancy in a single dose of 2 g

Group A: Screen-and-Treat Strategy

Clotrimazole, Vaginal DRUG

In case of Candida albicans infection in a single dose to be repeated up to 6 times if necessary.

Group A: Screen-and-Treat Strategy

Usual Care OTHER

Patients will not be screened using molecular biology techniques in this group. The management of these patients is a matter of routine for health professionals. They will be free to prescribe a standard vaginal swab if symptoms are present and to treat their patients according to their usual protocols. No routine sampling is recommended in the absence of a history

Group B: Control Group/Usual Care or Standard Strategy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women at high risk of preterm birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women over 18 years of age
• Pregnant woman after 8 weeks and before 18 weeks of gestation (i.e. \>=8 weeks and ≤ 18 weeks)
• Woman who has understood the study process and objectives and agreed to sign an informed consent form;
• With a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population) (A late miscarriage or late fetal loss mean foetal loss between 14 and 22 weeks of gestation)
• Affiliated to a social security regimen or equivalent

You may not qualify if:

• \- 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
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Vaginosis, Bacterial; Premature Birth

Interventions

Azithromycin; Ceftriaxone; Metronidazole; Clotrimazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Franceline CARTIER

CONTACT

+33491381927; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 5, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share