Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT06396078

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Led by Ohio State University · Updated on 2026-01-27

56

Participants Needed

2

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to the inpatient unit for expectant management of PPROM until delivery
  • Age 18 years or older with the ability to provide informed consent
  • Gestational age between 23 0/7 and 32 6/7 weeks
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States, 43210

Actively Recruiting

2

University of Texas Medical Branch

Galveston, Texas, United States, 775555

Actively Recruiting

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Research Team

M

Marissa Berry, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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