NCT06917157

Latency Antibiotics for Previable Rupture Of Membranes Trial

Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.

Conditions

• Preterm Prelabor Rupture of Membranes (PPROM)

Interventions

Type	Name	Description
DRUG	Administration of antibiotics prophylactically at the time of membrane rupture	Participants will receive the antibiotic regimen: * Day 1: Oral Azithromycin 1 g once and intravenous Ampicillin 2 g every 6 hours * Day 2: Intravenous Ampicillin 2 g every 6 hours * Days 3-7: Oral Amoxicillin 500 mg every 8 hours
DRUG	Administration of antibiotics non-prophylactically at 22 weeks	Participants will receive latency antibiotics starting 22 weeks 0 days: * Day 1: Oral Azithromycin 1 g once and intravenous Ampicillin 2 g every 6 hours * Day 2: Intravenous Ampicillin 2 g every 6 hours * Days 3-7: Oral Amoxicillin 500 mg every 8 hours

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study