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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to check and treat vaginal health issues in pregnant women who are at high risk of having their babies early (before 37 weeks). The researchers want to see if a method using advanced molecular testing, done before 18 weeks of pregnancy, can help reduce the chances of preterm birth by identifying and treating conditions like bacterial vaginosis (BV). BV is a common imbalance in the vaginal bacteria that can increase the risk of early delivery. The goal is to find out if this innovative approach can lower premature birth rates by 40%.

To participate in the trial, women must be over 18 years old, currently pregnant between 8 and 18 weeks, and have a history of preterm birth or late miscarriage. Participants will receive information about the study and need to agree to take part by signing a consent form. Those who qualify will undergo screening and may receive treatment for any identified vaginal health issues. It's important to know that certain women, such as those with specific medical conditions or currently involved in other clinical trials, won't be eligible for this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • - 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
• • Woman having received anti-infective treatment in the week preceding inclusion