Health Trials

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

Locations

2
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine43210, ColumbusOhio, United States
University of Texas Medical Branch775555, GalvestonTexas, United States

Sponsors and collaborators

Ohio State University

Lead sponsor

Source ClinicalTrials.gov