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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

1,292

Participants

Timeline

Start Date

August 31, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

January 31, 2028

Conditions
Bacterial VaginosisVaginal DysbiosisPremature Delivery
Interventions
DIAGNOSTIC_TEST

Vaginal flora abnormalities screening and quantification using molecular biology technique

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.

DRUG

Azithromycine

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)

DRUG

Ceftriaxone

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

DRUG

Metronidazole

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

DRUG

Clotrimazole, Vaginal

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

OTHER

Usual Care

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

All Listed Sponsors
lead

Assistance Publique Hopitaux De Marseille

OTHER

NCT06349122 - Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth | Biotech Hunter | Biotech Hunter