Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Launched by OHIO STATE UNIVERSITY · May 1, 2024

Keywords

ClinConnect Summary

The iPROMPT trial is studying a new way to manage a condition called Preterm Premature Rupture of Membranes (PPROM), which can happen when a pregnant person’s water breaks too early, before 34 weeks of pregnancy. Researchers want to see if a seven-day course of three antibiotics (ceftriaxone, clarithromycin, and metronidazole) can help prolong the pregnancy and improve outcomes for both the mother and baby, compared to the current standard treatment of two other antibiotics (ampicillin/amoxicillin and azithromycin or erythromycin).

To be eligible for this trial, participants need to be at least 18 years old, admitted to the hospital for PPROM management, and between 23 and 32 weeks pregnant. Participants should not have received more than one dose of any preventive antibiotics or have any infections that need treatment. If you join the trial, you will receive one of the two antibiotic treatments and will be monitored closely for seven days to see how it affects your pregnancy. This study is currently recruiting participants, and it aims to improve care for those facing this challenging condition.

Gender

FEMALE

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 antibiotic
• • Suspected or confirmed infection requiring treatment with antibiotics
• • Allergy or contraindication to an antibiotic in either arm
• • Maternal immunosuppression