Recruiting

Observational Study

Sponsor:

Pro-Lab Diagnostics

Code:

NCT02369601

Conditions

Fetal Membranes, Premature Rupture

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

non- intervention study

Study Details

Brief summary:

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.

Conditions

Fetal Membranes, Premature Rupture

Study ID

NCT02369601

Start date

Aug, 2015

Status verified date

Apr, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Interventions

non- intervention study

Study design is non-interventional. Patient therapy will not be affected by study participation.

Primary outcome measure

  • accuracy of Pro-mcomplete vs conventional testing for ruptured fetal membranes [ Time Frame: up to 20 weeks ]

Central Contacts and Locations

Central contacts

Andrew Rae

+1 905 731 0300arae@pro-lab.com

Chris Dunn

512-626-2590chris.dunn@pro-lab.com

Locations

University of Alabama Hospital

Recruiting

Birmingham, Alabama, United States

Principal Investigator:

Alan Tita, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Jessica Mockler

jelyroby@iupui.edu

Principal Investigator:

David Haas, MD

University of Texas Health Sciences Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Omeotl Acosta, M.D.

Acostao@uthscsa.edu

Principal Investigator:

Omeotl Acosta, M.D.

Christus Santa Rosa Westover Hills

Recruiting

San Antonio, Texas, United States, 78251

Contacts

Carlos Quezada, M.D.

drpapiq@gmail.com

Principal Investigator:

Carlos Quezada, M.D.

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States

Principal Investigator:

Erin Clark, MD

More Information

Sponsor

Pro-Lab Diagnostics

Last update posted

Apr 25, 2018

Last verified

Apr, 2018

Keywords

  • amniorrhexis
  • Ruptured membranes
  • Alfa-fetoprotein

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pro-Lab Diagnostics on 2018-04-25.