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AzTrials

Pregnancy RelatedNCT04158401

Cervical Stiffness Measurement in Cervical Insufficiency

An observational study of Pregnancy Related and Cervical Insufficiency, run by Tufts Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Pregnolia
Type of treatment
Medical device
How many people
136 participants
Where
1 siteUnited States
Study dates
15 Jan 2020to 15 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tufts Medical Center

    Boston, Massachusetts, 02122

Other trials in United States

About this study

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.

Being tested
Pregnolia
Medical subject headings
Uterine Cervical Incompetence, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PregnoliaDevice

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

Study groups in NCT04158401
Study groupRoleWhat they receive
Control groupPregnant patients between 12w0d and 22w0d who present for prenatal care.
Receives: Device: Pregnolia
Cerclage group APatients who present for a history-indicated cerclage placement.
Receives: Device: Pregnolia
Cerclage group BPatients who present for an ultrasound-indicated cerclage placement.
Receives: Device: Pregnolia
Cerclage group CPatients who present for an exam-indicated cerclage placement.
Receives: Device: Pregnolia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical stiffness (Pcl)

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

    Measured: 5 minutes

Secondary outcomes (2)

  1. Delivery data

    Patient delivery data including gestational age, mode of delivery and complications will be recorded

    Measured: up to 10 months

  2. Newborn outcomes

    Newborn outcomes including weight, APGARs and complications will be recorded

    Measured: up to 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2019
  2. Study start15 Jan 2020
  3. Primary completion15 Jun 2022
  4. Study completion15 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04158401
Sponsor's protocol ID
13549
Status last verified
Sep 2022
First submitted
23 Oct 2019
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lorenz JM. The outcome of extreme prematurity. Semin Perinatol. 2001 Oct;25(5):348-59. doi: 10.1053/sper.2001.27164.

    PubMed 11707021

  • 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.

    PubMed 18177778

  • 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.

    PubMed 12962929

  • 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.

    PubMed 7726247

  • 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.

    PubMed 20428351

  • 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.

    PubMed 24155152

  • 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.

    PubMed 23876854

  • 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.

    PubMed 23274486

  • 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.

    PubMed 23553612

  • 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.

    PubMed 19285777

  • 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.

    PubMed 17363446

  • 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.

    PubMed 16143559

  • 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.

    PubMed 17719834

  • 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.

    PubMed 24451674

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Related and Cervical Insufficiency, run by Tufts Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical stiffness (Pcl) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04158401, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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