Azithromycin and Ampicillin for Late PPROM (NCT07183462) | Clinical Trial Compass
RecruitingPhase 4
Azithromycin and Ampicillin for Late PPROM
Israel311 participantsStarted 2025-09-10
Plain-language summary
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 affect the time between membrane rupture and delivery, maternal infections, and the need for neonatal intensive care.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A composite of neonatal adverse outcomes
Timeframe: From the time of birth until 72 hours postpartum