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

NCT02092688 | Completed

• 1 other identifier: 140/13
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labour; Preterm Birth

Keywords

time to delivery; PROM; PTL; positive predictive value

Outcome Measures

Primary Outcomes (1)

• Time to delivery

  Measured in days

  3 months

Secondary Outcomes (14)

• Number of patients who have a positive PAMG-1-Test and deliver within 48 hours, 7 days and 14 days after taking the test

  3 months

• 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

  3 months

• Time of delivery

  37 weeks

• Number of babies admitted to NICU

  3 months

• Number of babies with histological chorioamnionitis

  3 months

Study Arms (2)

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

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

Interventions

novel kit for the detection of PAMG-1 DEVICE

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; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• AmniSure International LLC: collaborator

Study Sites (1)

Prof. Dr. Daniel Surbek

Bern, 3010, Switzerland

Location

Related Publications (6)

• Di Renzo GC, Roura LC, Facchinetti F, Antsaklis A, Breborowicz G, Gratacos E, Husslein P, Lamont R, Mikhailov A, Montenegro N, Radunovic N, Robson M, Robson SC, Sen C, Shennan A, Stamatian F, Ville Y. Guidelines for the management of spontaneous preterm labor: identification of spontaneous preterm labor, diagnosis of preterm premature rupture of membranes, and preventive tools for preterm birth. J Matern Fetal Neonatal Med. 2011 May;24(5):659-67. doi: 10.3109/14767058.2011.553694. Epub 2011 Mar 2. No abstract available.

  PMID: 21366393 BACKGROUND

• Gungorduk K, Asicioglu O, Besimoglu B, Gungorduk OC, Yildirm G, Ark C, Sahbaz A. Labor induction in term premature rupture of membranes: comparison between oxytocin and dinoprostone followed 6 hours later by oxytocin. Am J Obstet Gynecol. 2012 Jan;206(1):60.e1-8. doi: 10.1016/j.ajog.2011.07.035. Epub 2011 Jul 30.

  PMID: 21924396 BACKGROUND

• Kurdoglu M, Kolusari A, Adali E, Yildizhan R, Kurdoglu Z, Kucukaydin Z, Kaya A, Kirimi E, Sahin HG, Kamaci M. Does residual amniotic fluid after preterm premature rupture of membranes have an effect on perinatal outcomes? 12 years experience of a tertiary care center. Arch Gynecol Obstet. 2010 Apr;281(4):601-7. doi: 10.1007/s00404-009-1147-4. Epub 2009 Jun 12.

  PMID: 19521709 BACKGROUND

• Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet Gynecol. 2007 Mar;109(3):634-40. doi: 10.1097/01.AOG.0000252706.46734.0a.

  PMID: 17329514 BACKGROUND

• Lee SM, Lee J, Seong HS, Lee SE, Park JS, Romero R, Yoon BH. The clinical significance of a positive Amnisure test in women with term labor with intact membranes. J Matern Fetal Neonatal Med. 2009 Apr;22(4):305-10. doi: 10.1080/14767050902801694.

  PMID: 19350444 BACKGROUND

• Lee SM, Romero R, Park JW, Kim SM, Park CW, Korzeniewski SJ, Chaiworapongsa T, Yoon BH. The clinical significance of a positive Amnisure test in women with preterm labor and intact membranes. J Matern Fetal Neonatal Med. 2012 Sep;25(9):1690-8. doi: 10.3109/14767058.2012.657279. Epub 2012 Apr 25.

  PMID: 22280400 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Daniel Surbek, Prof. Dr. med.

  Geburtshilfe Frauenklinik Inselspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 20, 2014
• Study Start: December 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: March 31, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

CH (1)