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New treatment option for Preterm Premature Rupture of Membrane
Official title Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
ClinicalTrials.gov ID: NCT06396078
What this study is testing
What is Ceftriaxone 1000 MG?
Ceftriaxone 1000 MG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for preterm premature rupture of membrane.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
- Galveston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States; Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.