Cervical Stiffness Measurement in Cervical Insufficiency

NCT04158401 | Completed

• 1 other identifier: 13549
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Related; Cervical Insufficiency; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Cervical stiffness (Pcl)

  The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.

  5 minutes

Secondary Outcomes (2)

• Delivery data

  up to 10 months

• Newborn outcomes

  up to 10 months

Study Arms (4)

Control group

Pregnant patients between 12w0d and 22w0d who present for prenatal care.

Device: Pregnolia

Cerclage group A

Patients who present for a history-indicated cerclage placement.

Device: Pregnolia

Cerclage group B

Patients who present for an ultrasound-indicated cerclage placement.

Device: Pregnolia

Cerclage group C

Patients who present for an exam-indicated cerclage placement.

Device: Pregnolia

Interventions

Pregnolia DEVICE

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

Cerclage group A; Cerclage group B; Cerclage group C; Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients need to be pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are studying pregnant patients between 12w0d and 22w6d.

You may qualify if:

• Pregnant women over 18 years of age.
• Singleton gestation.
• Gestational ages between 12w0d and 22w6d.
• Candidates for cerclage
• Normal controls, which will be matched to cerclage subjects by gestational age and parity

You may not qualify if:

• Multiple gestation pregnancy.
• Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.
• Chorioamnionitis
• Preterm contractions
• History of cervical surgery (LEEP, trachelectomy, conization).
• Mullarian anomaly
• Known carrier or HIV or Hepatitis B/C
• Active genital infection
• Communication problems (cognitively impaired adults unable to give consent)
• Cerclage placement already performed this pregnancy

Sponsors & Collaborators

• Tufts Medical Center: lead
• Pregnolia AG: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02122, United States

Location

Related Publications (14)

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  PMID: 11707021 BACKGROUND

• 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.

  PMID: 18177778 BACKGROUND

• 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. doi: 10.1016/s0029-7844(03)00617-3.

  PMID: 12962929 BACKGROUND

• 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. doi: 10.1016/0002-9378(95)91469-2.

  PMID: 7726247 BACKGROUND

• 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.

  PMID: 20428351 BACKGROUND

• 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. doi: 10.1002/pd.4260.

  PMID: 24155152 BACKGROUND

• 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.

  PMID: 23876854 BACKGROUND

• 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.

  PMID: 23274486 BACKGROUND

• 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.

  PMID: 23553612 BACKGROUND

• 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.

  PMID: 19285777 BACKGROUND

• 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. doi: 10.1196/annals.1389.004. Epub 2007 Mar 15.

  PMID: 17363446 BACKGROUND

• 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. doi: 10.1016/j.media.2005.06.001. Epub 2005 Sep 6.

  PMID: 16143559 BACKGROUND

• 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. doi: 10.1016/j.media.2007.06.010. Epub 2007 Jul 5.

  PMID: 17719834 BACKGROUND

• 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.

  PMID: 24451674 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Incompetence; Premature Birth

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Michael House, MD

  Tufts Medical Center

  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: October 23, 2019
• First Posted: November 8, 2019
• Study Start: January 15, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

US (1)