Treatment of ppROM With Erythromycin vs. Azithromycin Trial

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This pregnancy complication is a major contributor to preterm births and results in neonatal morbidity and mortality. The current standard of care for PPROM subjects between the gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do not tolerate this regimen over the course of 7 days. In addition, there is a national shortage of erythromycin, and published expert opinion proposed to use a second-generation macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The investigators' working hypothesis is that there is no measurable difference in the primary outcome between the group randomized to the azithromycin regimen versus the group randomized to the erythromycin regimen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Amoxicillin; Ampicillin; Azithromycin; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

Criteria

Inclusion Criteria:

• Maternal age ≥ 18 years and <50 years

• Pregnant women between the gestational age 23 6/7 and 32 6/7 weeks

• Singleton pregnancy

• Preterm premature rupture of membranes, determined clinically

• Cervical dilation visually ≤ 5cm on sterile speculum exam.

• Planned delivery at John Sealy Hospital (JSH)

Exclusion Criteria:

• Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)

• Any contraindication to expectant management (e.g. fetal compromise, chorioamnionitis, placental abruption)

• Cervical cerclage in place

• Placenta previa or other known placental anomalies

• Contraindication to any of the antibiotics used (allergy to macrolides).

• Enrolled in another trial that may affect outcome.

• Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention.

• No prenatal care (less than 2 prenatal visits)

• Non-resident subject who is unlikely to be followed-up after delivery

• Any fetal congenital anomaly.

• Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal

• Significant renal disease defined as serum creatinine known to be >2.0 mg/dl or on dialysis.

• Active congestive heart failure (EF<45%) or pulmonary edema.

• Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other.