PROMComplete for Determination of Rupture of Fetal Membranes
Launched by PRO-LAB DIAGNOSTICS · Feb 23, 2015
Trial Information
Current as of August 11, 2025
Unknown status
Keywords
ClinConnect Summary
Premature rupture of membranes (PROM) complicates approximately 8 % of pregnancies and is generally followed by the prompt onset of spontaneous labor and delivery. Preterm PROM complicates only 2 % of pregnancies but is associated with 40% of preterm deliveries and can result in significant neonatal morbidity and mortality (ACOG 2007). Intraamniotic infection has been shown to be commonly associated with preterm PROM, especially at earlier gestational ages (ACOG 2013). Currently, the diagnosis of PROM is based primarily on the patient's history and physical examination. The diagnosis of mem...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 1. Subject has provided verbal and written informed consent to participate in the study.
- • 2. 20-42 weeks of gestation.
- • 3. Subject presents with signs and/or symptoms of premature rupture of membranes.
- • 4. Subject age 18 (years) or older
- Exclusion Criteria:
- • 1. Placenta Previa
- • 2. Presenting with vaginal bleeding
- • 3. Intravaginal ultrasound with presence of transducer gel
- • 4. Active labor
- • 5. Imminent delivery
- • 6. Intercourse within 24 hours
- • 7. Cord prolapse
About Pro Lab Diagnostics
Pro-Lab Diagnostics is a leading provider of innovative diagnostic solutions, committed to enhancing healthcare outcomes through advanced laboratory testing and analysis. With a focus on quality and reliability, the company develops a wide range of diagnostic products that empower healthcare professionals to make informed decisions. Pro-Lab Diagnostics is dedicated to advancing research and clinical trials, ensuring that their contributions support the development of effective treatments and enhance patient care across various medical fields. Through a combination of cutting-edge technology and a robust understanding of clinical needs, Pro-Lab Diagnostics remains at the forefront of the diagnostics industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
San Antonio, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Birmingham, Alabama, United States
Patients applied
Trial Officials
Andrew Rae
Study Director
Pro-Lab Diagnostic VP
Hector Chapa, M.D.
Principal Investigator
Methodist Medical Center Dallas
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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