Latency Antibiotics for Previable Rupture Of Membranes Trial

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Mar 31, 2025

Keywords

ClinConnect Summary

The Latency Antibiotics for Previable Rupture Of Membranes Trial is a study that aims to find out if giving antibiotics to pregnant women with preterm premature rupture of membranes (PPROM)—when the water breaks before 22 weeks of pregnancy—can help reduce the chances of delivering within a week. The study will also look at whether these antibiotics can lower the risk of health problems for the baby after delivery.

To participate in this trial, women must be less than 22 weeks pregnant with a singleton baby, have had their membranes rupture within the last 36 hours, and have a cervix that is 3 cm dilated or less. They should not have any immediate reasons for delivery or certain medical conditions, such as bleeding or infections. If eligible, participants will receive antibiotics as part of their care and will be monitored closely. This trial is not yet recruiting, but it represents an important step in understanding better care for pregnancies affected by PPROM.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Preterm premature rupture of membranes at less than 22 weeks.
• • Membrane rupture had occurred within 36 hours of randomization.
• • Cervical dilatation is 3 cm or less (on visual or clinical examination).
• • 4 or fewer contractions in the 60-minute monitoring period before randomization.
• • Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
• • Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.
• Exclusion Criteria:
• • Nonreasoning fetal testing
• • Vaginal bleeding
• • Maternal or fetal indication for immediate delivery
• • Cervical cerclage in place
• • Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)
• • Allergy to Penicillins or Azithromycin
• • Febrile illness requiring antibiotics
• • Placenta previa
• • Multifetal gestation