Cervical Stiffness Measurement in Cervical Insufficiency

Overview

The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies.

The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix.

In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2021

Interventions

  • Device: Pregnolia
    • The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.

Arms, Groups and Cohorts

  • Control group
    • Pregnant patients between 12w0d and 22w0d who present for prenatal care.
  • Cerclage group A
    • Patients who present for a history-indicated cerclage placement.
  • Cerclage group B
    • Patients who present for an ultrasound-indicated cerclage placement.
  • Cerclage group C
    • Patients who present for an exam-indicated cerclage placement.

Clinical Trial Outcome Measures

Primary Measures

  • Cervical stiffness (Pcl)
    • Time Frame: 5 minutes
    • The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.

Secondary Measures

  • Delivery data
    • Time Frame: up to 10 months
    • Patient delivery data including gestational age, mode of delivery and complications will be recorded
  • Newborn outcomes
    • Time Frame: up to 10 months
    • Newborn outcomes including weight, APGARs and complications will be recorded

Participating in This Clinical Trial

Inclusion Criteria

1. Pregnant women over 18 years of age.

2. Singleton gestation.

3. Gestational ages between 12w0d and 22w6d.

4. Candidates for cerclage

5. Normal controls, which will be matched to cerclage subjects by gestational age and parity

Exclusion Criteria

1. Multiple gestation pregnancy.

2. Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.

3. Chorioamnionitis

4. Preterm contractions

5. History of cervical surgery (LEEP, trachelectomy, conization).

6. Mullarian anomaly

7. Known carrier or HIV or Hepatitis B/C

8. Active genital infection

9. Communication problems (cognitively impaired adults unable to give consent)

10. Cerclage placement already performed this pregnancy

Gender Eligibility: Female

Patients need to be pregnant.

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tufts Medical Center
  • Collaborator
    • Pregnolia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael House, MD, Principal Investigator, Tufts Medical Center
  • Overall Contact(s)
    • House Michael, MD, 617-636-3200, mhouse@tuftsmedicenter.org

References

Lorenz JM. The outcome of extreme prematurity. Semin Perinatol. 2001 Oct;25(5):348-59. Review.

Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4. Review.

Gilbert WM, Nesbitt TS, Danielsen B. The cost of prematurity: quantification by gestational age and birth weight. Obstet Gynecol. 2003 Sep;102(3):488-92.

Iams JD, Johnson FF, Sonek J, Sachs L, Gebauer C, Samuels P. Cervical competence as a continuum: a study of ultrasonographic cervical length and obstetric performance. Am J Obstet Gynecol. 1995 Apr;172(4 Pt 1):1097-103; discussion 1104-6.

Beck S, Wojdyla D, Say L, Betran AP, Merialdi M, Requejo JH, Rubens C, Menon R, Van Look PF. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010 Jan;88(1):31-8. doi: 10.2471/BLT.08.062554. Epub 2009 Sep 25. Review.

Mazza E, Parra-Saavedra M, Bajka M, Gratacos E, Nicolaides K, Deprest J. In vivo assessment of the biomechanical properties of the uterine cervix in pregnancy. Prenat Diagn. 2014 Jan;34(1):33-41. Review.

Hollenstein M, Bugnard G, Joos R, Kropf S, Villiger P, Mazza E. Towards laparoscopic tissue aspiration. Med Image Anal. 2013 Dec;17(8):1037-45. doi: 10.1016/j.media.2013.06.001. Epub 2013 Jun 19.

Badir S, Bajka M, Mazza E. A novel procedure for the mechanical characterization of the uterine cervix during pregnancy. J Mech Behav Biomed Mater. 2013 Nov;27:143-53. doi: 10.1016/j.jmbbm.2012.11.020. Epub 2012 Dec 11.

Badir S, Mazza E, Zimmermann R, Bajka M. Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique. Prenat Diagn. 2013 Aug;33(8):737-41. doi: 10.1002/pd.4116. Epub 2013 Apr 29.

Bauer M, Mazza E, Jabareen M, Sultan L, Bajka M, Lang U, Zimmermann R, Holzapfel GA. Assessment of the in vivo biomechanical properties of the human uterine cervix in pregnancy using the aspiration test: a feasibility study. Eur J Obstet Gynecol Reprod Biol. 2009 May;144 Suppl 1:S77-81. doi: 10.1016/j.ejogrb.2009.02.025. Epub 2009 Mar 13.

Bauer M, Mazza E, Nava A, Zeck W, Eder M, Bajka M, Cacho F, Lang U, Holzapfel GA. In vivo characterization of the mechanics of human uterine cervices. Ann N Y Acad Sci. 2007 Apr;1101:186-202. Epub 2007 Mar 15. Review.

Mazza E, Nava A, Bauer M, Winter R, Bajka M, Holzapfel GA. Mechanical properties of the human uterine cervix: an in vivo study. Med Image Anal. 2006 Apr;10(2):125-36. Epub 2005 Sep 6.

Mazza E, Nava A, Hahnloser D, Jochum W, Bajka M. The mechanical response of human liver and its relation to histology: an in vivo study. Med Image Anal. 2007 Dec;11(6):663-72. Epub 2007 Jul 5.

American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No.142: Cerclage for the management of cervical insufficiency. Obstet Gynecol. 2014 Feb;123(2 Pt 1):372-9. doi: 10.1097/01.AOG.0000443276.68274.cc.

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