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Latency Antibiotics for Previable Rupture Of Membranes Trial

NCT06917157 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2026-05-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Khalil Chahine, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-31
Completion
2027-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917157 on ClinicalTrials.gov