Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06396078
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pregnancy, High Risk
  • Preterm Birth
  • Preterm Premature Rupture of Membrane

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ceftriaxone 1000 MG — DRUG
    Ceftriaxone 1 g IV q 24 hours x 7 days (in addition to clarithromycin and metronidazole)
  • Clarithromycin 500mg — DRUG
    Clarithromycin 500 mg PO BID x 7 days (in addition to ceftriaxone and metronidazole)
  • Metronidazole 500 mg — DRUG
    Metronidazole 500 mg PO q 12 hours x 7 days (in addition to clarithromycin and ceftriaxone)
  • Ampicillin 2 GM Injection — DRUG
    Ampicillin 2 g IV q 6 hours x 48 hours (prior to amoxicillin and in addition to either azithromycin or erythromycin)
  • Amoxicillin 250 MG — DRUG
    Amoxicillin 250 mg q 8 hours for an additional 5 days (following ampicillin and in addition to either azithromycin or erythromycin)
  • Azithromycin — DRUG
    Azithromycin 1 g PO x 1 dose (in addition to ampicillin and amoxicillin)
  • Erythromycin — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jul 18, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    Participants randomized to the intervention group will receive the following regimen: * Ceftriaxone 1 g IV q 24 hours x 7 days * Clarithromycin 500 mg PO BID x 7 days * Metronidazole 500 mg PO q 12 hours x 7 days
  • Other: Standard of care
    Participants randomized to the standard care group will receive the following regimen: * Ampicillin 2 g IV q 6 hours x 48 hours followed by amoxicillin 250 mg q 8 hours for an additional 5 days * Azithromycin 1 g PO x 1 dose OR erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days

Primary Outcome Measure

Latency [ Time Frame: From randomization to delivery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Marissa Berry, MD
[email protected]
614-293-4780
University of Texas Medical BranchGalvestonTexas775555
Benjamin Spires, MD
[email protected]
409-772-1193
Luis D Pacheco, MD
[email protected]

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By research site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine· Columbus, OHUniversity of Texas Medical Branch· Galveston, TX

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