Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
Recruiting
Phase 4
Interventional Study
Preterm Premature Rupture of Membrane
Pregnancy, High Risk
Preterm Birth
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 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 56 (estimated)
- Sponsor
- Ohio State University · Other
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About This Trial
To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcom…
Trial Locations
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Eligibility Criteria
Inclusion criteria
* Admitted to the inpatient unit for expectant management of PPROM until delivery
* Age ≥ 18 years with the ability to provide informed consent
* Gestational age between 23 0/7 and 32 6/7 weeks
Exclusion criteria
* Having received more than one dose of any prophylactic antibiot…
Contacts