NCT06396078View on ClinicalTrials.gov

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

PHASE4RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

July 18, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Preterm Premature Rupture of MembranePregnancy, High RiskPreterm Birth
Interventions
DRUG

Ceftriaxone 1000 MG

Ceftriaxone 1 g IV q 24 hours x 7 days (in addition to clarithromycin and metronidazole)

DRUG

Clarithromycin 500mg

Clarithromycin 500 mg PO BID x 7 days (in addition to ceftriaxone and metronidazole)

DRUG

Metronidazole 500 mg

Metronidazole 500 mg PO q 12 hours x 7 days (in addition to clarithromycin and ceftriaxone)

DRUG

Ampicillin 2 GM Injection

Ampicillin 2 g IV q 6 hours x 48 hours (prior to amoxicillin and in addition to either azithromycin or erythromycin)

DRUG

Amoxicillin 250 MG

Amoxicillin 250 mg q 8 hours for an additional 5 days (following ampicillin and in addition to either azithromycin or erythromycin)

DRUG

Azithromycin

Azithromycin 1 g PO x 1 dose (in addition to ampicillin and amoxicillin)

DRUG

Erythromycin

Erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days (in addition to ampicillin and amoxicillin)

Trial Locations (2)

43210

RECRUITING

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

775555

RECRUITING

University of Texas Medical Branch, Galveston

All Listed Sponsors
lead

Ohio State University

OTHER