Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

ConditionsPreterm Premature Rupture of Membrane Pregnancy, High Risk Preterm Birth

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18+

SponsorOhio State University

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 outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.

Eligibility criteria

Qualifiers

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

Disqualifiers

Having received more than one dose of any prophylactic antibiotic

Suspected or confirmed infection requiring treatment with antibiotics

Allergy or contraindication to an antibiotic in either arm

Maternal immunosuppression

Trial design

Treatments tested in this trial

Ceftriaxone 1000 MG
Clarithromycin 500mg
Metronidazole 500 mg
Ampicillin 2 GM Injection
Amoxicillin 250 MG
Azithromycin
Erythromycin

Treatment groups

56 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Ohio State University

Lead sponsor

Source ClinicalTrials.gov