Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ceftriaxone 1000 MG, Clarithromycin 500mg, Metronidazole 500 mg, Ampicillin 2 GM Injection.
- Who it may be relevant to
- Registry conditions: Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy
Overview
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.
Detailed description
Preterm prelabor rupture of membranes (PPROM) is the most common identifiable risk factor associated with preterm birth and affects 1 in 3 pregnant individuals in the United States with spontaneous preterm birth. Individuals diagnosed with PPROM who meet criteria for expectant management are currently admitted to the hospital for observation until delivery, which is generally recommended at 34 weeks' gestation unless indicated sooner. Initially upon admission, a course of prophylactic antibiotics is administered as this has been shown to prolong pregnancy and improve neonatal outcomes. The standard antibiotic regimen, primarily based on data published in 1997, includes ampicillin followed by amoxicillin with erythromycin or azithromycin for a total of 7 days. Ongoing studies are needed to determine the optimal prophylactic antibiotic regimen given changes in bacterial sensitivities over time, lack of adequate coverage for common organisms including genital mycoplasma, inadequate placental transfer of currently used antibiotic agents, ineffective antibiotic response at reducing the fetal inflammatory response, and new promising antibiotic agents that address these limitations. A promising expanded-spectrum alternative regimen with proof-of-concept is ceftriaxone, clarithromycin, and metronidazole. Observational studies have shown successful eradication of intraamniotic inflammation/infection using this new regimen. This regimen offers multiple potential advantages, including: higher bioavailability, higher transplacental transfer, and effectiveness against genital mycoplasma (clarithromycin), greater anaerobic coverage (metronidazole), and a longer half-life and expanded coverage against gram-negative bacteria (ceftriaxone) compared with the current standard regimen.
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)
Primary outcome measures
- Latency [Time frame: From randomization to delivery]
Secondary outcome measures (8)
- Neonatal outcome composite checklist [Time frame: From birth to up to 6 weeks postpartum]
- Endometritis [Time frame: From birth to up to 6 weeks postpartum]
- Surgical site infection [Time frame: From birth to up to 6 weeks postpartum]
- Individual clinical infections [Time frame: From birth to up to 6 weeks postpartum]
- Puerperal fever [Time frame: From birth to up to 6 weeks postpartum]
- Histopathologic chorioamnionitis/funisitis on histologic placental evaluation [Time frame: From randomization to delivery]
- Antibiotic receipt postpartum [Time frame: From birth to up to 6 weeks postpartum]
- Adverse events [Time frame: From randomization to delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus
- University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT06396078 · 2024H0122