RecruitingPhase 4NCT06396078

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy

Sponsor

Ohio State University

Enrollment

56 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Pregnancy, High Risk Preterm Birth Preterm Premature Rupture of Membrane

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amoxicillin 250 MG, a drug called Ampicillin 2 GM Injection, and others for people with pregnancy, high risk, preterm birth, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCeftriaxone 1000 MG

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

DRUGClarithromycin 500mg

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

DRUGMetronidazole 500 mg

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

DRUGAmpicillin 2 GM Injection

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

DRUGAmoxicillin 250 MG

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

DRUGAzithromycin

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

DRUGErythromycin

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)

Locations(2)

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

Columbus, Ohio, United States

University of Texas Medical Branch

Galveston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06396078

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