PROMComplete for Determination of Rupture of Fetal Membranes

Status unconfirmed

Conditions studied: Fetal Membranes, Premature Rupture

In brief

Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased incidence of perinatal mortality and intra-amniotic infection. There is a need for improved diagnostic testing because of limitations of the current methods. PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.

Key facts

Study ID

NCT02369601

Run by

Pro-Lab Diagnostics

People needed

600

Starts

2015-08-01

Expected to finish

2018-12-01

Last updated by the study team

2018-04-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided verbal and written informed consent to participate in the study.
• 20-42 weeks of gestation.
• Subject presents with signs and/or symptoms of premature rupture of membranes.
• Subject age 18 (years) or older

You may not qualify if…

• Placenta Previa
• Presenting with vaginal bleeding
• Intravaginal ultrasound with presence of transducer gel
• Active labor
• Imminent delivery
• Intercourse within 24 hours
• Cord prolapse

Where it is running

• University of Alabama Hospital — Birmingham, Alabama, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Texas Health Sciences Center at San Antonio — San Antonio, Texas, United States (enrolling)
• Christus Santa Rosa Westover Hills — San Antonio, Texas, United States (enrolling)
• University of Utah Hospital — Salt Lake City, Utah, United States (enrolling)
• Methodist Hospital Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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