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RecruitingPhase 3NCT06273891

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes: A Cluster Randomized Comparative Effectiveness Trial

Sponsor

Inova Health Care Services

Enrollment

140 participants

Start Date

Mar 8, 2024

Study Type

INTERVENTIONAL

Conditions

Premature Rupture of Membrane

Summary

The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

  • Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation.
  • Rupture of membranes confirmed by biochemical testing.
  • Membrane rupture within the past 36 hours.
  • Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission.
  • Age ≥18 and <50 years.

Exclusion Criteria3

  • Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission.
  • Allergy to penicillin, erythromycin, or azithromycin.
  • Multiple gestations.

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Interventions

DRUGErythromycin

Erythromycin 250 mg IV every 6 hours for 48 hours, followed by 250 mg PO or 333 mg PO every 8 hours for 5 days in addition to Ampicillin 2 gm IV every 6 hours for 2 days followed by Amoxicillin 250 mg PO every 8 hours for 5 days

DRUGAzithromycin

Azithromycin 1 gm PO once or 500 mg PO followed by 250 mg PO daily for a total of 5 days in addition to Ampicillin 2 gm IV every 6 hours for 2 days followed by Amoxicillin 250 mg PO every 8 hours for 5 days

Locations(2)

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Eastern Viriginia Medical School

Norfolk, Virginia, United States

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NCT06273891