Cervical Stiffness Measurement in Cervical Insufficiency

Pregnancy Related Clinical Trial

Official title:

Cervical Stiffness Measurement in Cervical Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158401
• Other study ID #: 13549
• Status: Completed
• Start date: January 15, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: September 2022
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Insufficiency
• Pregnancy Related
• Premature Birth
• Preterm Birth
• Uterine Cervical Incompetence

Intervention

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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Pregnolia AG

Country where clinical trial is conducted

United States, 

References & Publications (14)

ACOG Practice Bulletin No.142: Cerclage for the management of cervical insufficiency. Obstet Gynecol. 2014 Feb;123(2 Pt 1):372-379. doi: 10.1097/01.AOG.0000443276.68274.cc. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical stiffness (Pcl)	The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.	5 minutes
Secondary	Delivery data	Patient delivery data including gestational age, mode of delivery and complications will be recorded	up to 10 months
Secondary	Newborn outcomes	Newborn outcomes including weight, APGARs and complications will be recorded	up to 10 months