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Echec-MAT - A combination of antibiotics to improve neonatal mortality and morbidity for pregnancies complicated with previable labour and intact membranes: an open multiple center, randomized, and controlled trial
EU CTIS ID: 2023-505500-37-00
What this study is testing
Reduce neonatal mortality and severe morbidity by prolonging pregnancies complicated by the threat of late miscarriage with intact membranes
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Threat of late miscarriage with intact membranes between 18 0/7 and 23 6/7 weeks of gestation, defined by transvaginal ultrasound as a cervix ≤10 mm, and/or protrusion of the amniotic sac observed with a speculum.
- Singleton pregnancy
- Living fetus at the time of inclusion
- Maternal age >18 years
- Absence of regular and painful uterine contractions
- Adequate understanding of the French language
You likely can't join if
- Preterm labor defined by regular and painful uterine contractions, and a short cervix
- Patient under state medical aid (AME) if not exempted from the affiliation requirement
- Protected person (patient under guardianship/curatorship/legal protection)
- Multiple pregnancies
- Premature rupture of membranes
- Acute chorioamnionitis
See the full eligibility criteria
- Threat of late miscarriage with intact membranes between 18 0/7 and 23 6/7 weeks of gestation, defined by transvaginal ultrasound as a cervix ≤10 mm, and/or protrusion of the amniotic sac observed with a speculum.
- Singleton pregnancy
- Living fetus at the time of inclusion
- Maternal age >18 years
- Absence of regular and painful uterine contractions
- Adequate understanding of the French language
- Affiliated with social security
- Preterm labor defined by regular and painful uterine contractions, and a short cervix
- Patient under state medical aid (AME) if not exempted from the affiliation requirement
- Protected person (patient under guardianship/curatorship/legal protection)
- Multiple pregnancies
- Premature rupture of membranes
- Acute chorioamnionitis
- Contraindication to the antibiotics in the protocol
- Chromosomal anomaly, congenital malformation
- Patients who have received antibiotics before inclusion or who require antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.)
- Participation in another interventional research study or being in the exclusion period following a previous study involving human subjects, if applicable
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.