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NOT YET RECRUITING
NCT06917157
PHASE4

Latency Antibiotics for Previable Rupture Of Membranes Trial

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

Official title: Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05-01

Completion Date

2027-05-31

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States