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โ† Trials
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Azithromycin and Ampicillin for Late PPROM

RecruitingPhase 4Ages 18 Years - 50 YearsFemaleSheba Medical Center
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy. The main question it aims to answer is: Does the combination of ampicillin and azithromycin lower the risk of serious neonatal health problems compared to ampicillin alone? Researchers will compare two antibiotic regimens: Ampicillin alone, which is the current standard care Ampicillin with azithromycin, a broader regimen that may better prevent infections and prolong pregnancy Participants will: Receive one of the two antibiotic treatments during hospitalization. Be monitored until delivery for signs of infection and labor All participants will stay in the hospital until delivery. The study also looks at how the antibiotic choice may

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Maternal age 18-50 * Premature rupture of membranes * Gestational age 34.0 and 36.4 weeks * Singleton pregnancy Exclusion Criteria: * Multiple gestations * Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes) * Meconium stain amniotic fluid * Non-reassuring fetal heart rate or status * Maternal or fetal indication for labor: * Suspected Chorioamnionitis * Suspected placental abruption * Any maternal morbidity requiring labor * Cervical cerclage in place. * Major fetal malformation or known chromosomal abnormalities. * Stillbirth. * Sensitivity to Macrolides Antibiotics
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What it tests

  • Intravenous Ampicillin followed by Oral Amoxicillin
  • Ampicillin/Amoxicillin plus single-dose PO Azithromycin
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Where

1 site
Sheba medical center
Ramat Gan, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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