Azithromycin and Ampicillin for Late PPROM
Recruiting
Phase 4
Interventional Study
Pregnancy Complications, Infectious
Premature Birth
Neonatal Diseases and Abnormalities
Antibiotic Prophylaxis
Latency Period
Prematurity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 50
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 311 (estimated)
- Sponsor
- Sheba Medical Center · Government
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About This Trial
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 comp…
Trial Locations
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Eligibility Criteria
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 …
Contacts