Improving management of preterm premature rupture of membranes with antibiotics
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy
This study is testing if a new combination of antibiotics can help pregnant people with preterm premature rupture of membranes stay pregnant longer and have healthier babies compared to the usual treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Academic / other |
| Locations | 2 sites (Columbus, Ohio and 1 other locations) |
| Trial ID | NCT06396078 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a new antibiotic regimen consisting of ceftriaxone, clarithromycin, and metronidazole compared to the standard treatment of ampicillin/amoxicillin and azithromycin or erythromycin for pregnant individuals with preterm premature rupture of membranes (PPROM). The study aims to prolong pregnancy and reduce adverse perinatal outcomes by administering these antibiotics during hospitalization for expectant management. Participants will be randomly assigned to receive either treatment for a duration of seven days, and outcomes will be monitored to assess the efficacy of the new regimen. The trial is designed as an unblinded pragmatic randomized controlled trial to reflect real-world clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 and older, between 23 and 32 weeks of gestation, who are admitted for expectant management of PPROM.
Not a fit: Patients who have received more than one dose of prophylactic antibiotics or have a suspected or confirmed infection requiring treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pregnancy outcomes and reduced complications for patients with PPROM.
How similar studies have performed: Previous observational studies have shown success with similar antibiotic regimens, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio and 1 other locations
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (Recruiting)
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Marissa Berry, MD — Ohio State University
- Study coordinator: Marissa Berry, MD
- Email: Marissa.Berry@osumc.edu
- Phone: 614-293-4780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.