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Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth

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ClinicalTrials.gov Identifier: NCT02092688
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
AmniSure International LLC
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

This is a prospective observational trial that will enroll pregnant women between 24 and 36 6/7 weeks of gestation that present with signs and symptom of preterm labor with clinically intact membranes and cervical dilatation ≤ 3 cm and a control group of pregnant women without signs and risks for PTL to assess how the results of the novel kit for the detection of PAMG-1 in both patient groups correlate to their time-to-delivery (TTD) and other adverse neonatal and pregnancy outcomes.

Thes study hypothesis contains that the novel diagnostic kit will identify women who are at high risk for preterm birth by a high positive predictive value.


Condition or disease Intervention/treatment
Preterm Labour Preterm Birth Device: novel kit for the detection of PAMG-1

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor in Comparison to a Control Group of Asymptomatic Women With the Same Gestational Age - a Multicenter Trial
Study Start Date : December 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : March 31, 2017

Group/Cohort Intervention/treatment
Study group
Study group: women between 24 and 36 6/7 weeks of gestation that present with self-reported signs, symptoms or complaints suggestive of preterm labor
Device: novel kit for the detection of PAMG-1
The novel kit for the detection of PAMG-1 is a diagnostic device employing monoclonal antibodies that detect Placental α1 Microglobulin present in cervico-vaginal secretions manufactured by AmniSure® International, LLC, Boston, MA. The in vivo sensitivity detection threshold is 4ng/ml. During the test procedure, PAMG-1 from the sample sequentially binds to monoclonal antibody conjugated with labeled particles, then to monoclonal antibody immobilized on an insoluble carrier. The test requires a 30 second swab saturation in the vagina (a sterile speculum examination is not required), a 30 second active washing step whereby the swab just removed from the vagina is actively rotated in a solvent filled vial and lastly, a 5 minute waiting period from the time the swab is removed and the test strip is inserted if two testing lines do not appear sooner.

Control group
Control group: women between 24 and 36 6/7 weeks of gestation without signs or symptoms of PTL
Device: novel kit for the detection of PAMG-1
The novel kit for the detection of PAMG-1 is a diagnostic device employing monoclonal antibodies that detect Placental α1 Microglobulin present in cervico-vaginal secretions manufactured by AmniSure® International, LLC, Boston, MA. The in vivo sensitivity detection threshold is 4ng/ml. During the test procedure, PAMG-1 from the sample sequentially binds to monoclonal antibody conjugated with labeled particles, then to monoclonal antibody immobilized on an insoluble carrier. The test requires a 30 second swab saturation in the vagina (a sterile speculum examination is not required), a 30 second active washing step whereby the swab just removed from the vagina is actively rotated in a solvent filled vial and lastly, a 5 minute waiting period from the time the swab is removed and the test strip is inserted if two testing lines do not appear sooner.




Primary Outcome Measures :
  1. Time to delivery [ Time Frame: 3 months ]
    Measured in days


Secondary Outcome Measures :
  1. Number of patients who have a positive PAMG-1-Test and deliver within 48 hours, 7 days and 14 days after taking the test [ Time Frame: 3 months ]
  2. Number of patients who have a negative PAMG-1-Test and do not deliver within 48 hours, 7 days and 14 days after taking the test [ Time Frame: 3 months ]
  3. Time of delivery [ Time Frame: 37 weeks ]
    Measured in weeks

  4. Number of babies admitted to NICU [ Time Frame: 3 months ]
  5. Number of babies with histological chorioamnionitis [ Time Frame: 3 months ]
  6. Number of babies with respiratory distress syndrome [ Time Frame: 3 months ]
  7. Time to Delivery [ Time Frame: 3 months ]
    Measured in weeks; prolongation of delivery from administration

  8. Number of babies with infection [ Time Frame: 3 months ]
  9. Number of babies with intracranial hemorrhage [ Time Frame: 3 months ]
  10. Number of babies with necrotizing enterocolitis [ Time Frame: 3 months ]
  11. Number of babies with patent ductus arteriosus [ Time Frame: 3 months ]
  12. Number of babies with neonatal sepsis [ Time Frame: 3 months ]
  13. Birthweight [ Time Frame: 3 months ]
    Measured in grams

  14. Number of perinatal deaths [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women presenting with signs auf PTL at emergenca care and pregnant asymptomatic women presenting for routine check-up
Criteria

Inclusion Criteria:

  • Patients presenting for emergency obstetrical care at an emergency room or labor & delivery unit with signs, symptoms or complaints suggestive of preterm labor (PTL)
  • Gestational age between 24 and 36 6/7 weeks of gestation
  • Consenting to be part of the trial
  • Women between 24 and 36 6/7 weeks of gestation without signs or symptoms of PTL
  • Written informed consent

Exclusion Criteria

  • PROM
  • > 3 cm cervical dilatation
  • < 18 yrs old and not emancipated consenting minor
  • Heavy vaginal bleeding
  • Cervical dilatation > 3 centimeters
  • Suspected placenta previa
  • < 24 weeks of gestation or ≥ 37 weeks of gestation
  • Cervical cerclage in place or cervical pessary
  • A symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
  • Enrollment in a tocolytic study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092688


Locations
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Switzerland
Prof. Dr. Daniel Surbek
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
AmniSure International LLC
Investigators
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Principal Investigator: Daniel Surbek, Prof. Dr. med. Geburtshilfe Frauenklinik Inselspital
Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02092688    
Other Study ID Numbers: 140/13
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by University Hospital Inselspital, Berne:
time to delivery
PROM
PTL
positive predictive value
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications