Latency Antibiotics for Previable Rupture Of Membranes Trial

Phase 4Not Yet RecruitingNCT06917157

The University of Texas Health Science Center, Houston60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preterm Prelabor Rupture of Membranes (PPROM)

Interventions

Administration of antibiotics prophylactically at the time of membrane ruptureDRUG

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

Administration of antibiotics non-prophylactically at 22 weeksDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of participants that delivered their babies after membrane rupture

Time frame: from baseline to day 7

Secondary Outcomes

Latency, defined as the duration between rupture of membranes and delivery

Time frame: from rupture of membranes to delivery(about 1-126 days after baseline)

Number of participants that have Chorioamnionitis

Time frame: Baseline upto delivery (about 1-126 days after baseline)

Number of participants that develop sepsis

Time frame: From baseline upto discharge (about 1-4 days post delivery)

Number of maternal deaths

Time frame: From baseline upto discharge (about 1-4 days post delivery)

Number of admissions to intensive care unit (ICU)

Time frame: From baseline upto discharge (about 1-4 days post delivery)

Number of participants that develop postpartum hemorrhage

postpartum hemorrhage could occur during the following: 1. Transfusion 2. Non-elective hysterectomy 3. Use of two or more uterotonics other than oxytocin 4. Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization and hypogastric ligation, balloon tamponade 5. Curettage

Time frame: From baseline upto discharge (about 1-4 days post delivery)

Number of participants that develop maternal postpartum infection

Infection is defined as one of the following: * Clinical diagnosis of endometritis * Wound reopened for hematoma, seroma, infection or other reasons * Cellulitis requiring antibiotics * Pneumonia * Pyelonephritis * Bacteremia unknown source * Septic pelvic thrombosis

Central Contacts

Khalil Chahine, MD

CONTACT

(713) 500-6412 Khalil.Chahine@uth.tmc.edu

Baha Sibai

CONTACT

(713) 500-6421 Baha.M.Sibai@uth.tmc.edu

Data from ClinicalTrials.gov

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