Mechanical Environment Pregnancy With Short Cervix

NCT03865108 | Completed

• 2 other identifiers: AAAO4956 sub-study3UG1HD040485-18S1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to quantify the mechanical environment of pregnancies complicated by a short cervix and randomized in the Trial of Pessary in Singleton Pregnancies with a Short Cervix study with ultrasound imaging and aspiration. Aim 1: To determine the biomechanical properties of a prematurely remodeled cervix. Aim 2: To determine the impact of pessary placement on the biomechanical properties of a prematurely remodeled cervix and establish if the pessary reduces the mechanical load on the cervix through computer modeling informed by ultrasonographic measurement and cervical stiffness measurements. Aim 3: To determine if the differences in the cervical biomechanical properties after pessary placement lead to improved birth outcomes as compared to the progesterone only group.

Conditions

Preterm Birth

Keywords

Pessary; Cervix; Biomechanical environment; Aspiration; Computer simulation models

Outcome Measures

Primary Outcomes (1)

• Mechanical compliance index of the cervix

  The mechanical compliance index of the cervix is the percentage of the cervical tissue above a 1.2 stretch threshold under a uniform IUP. This index is calculated using finite element computational methods, given the maternal anatomy and cervical stiffness measured from the aspiration tool. The mechanical compliance index of the cervix will be measured at both time points within the study timeframe, and the change of the mechanical compliance index between the two time points will be assessed. The main outcome parameter will be the mechanical compliance index at the baseline time point, and the other two outcome measures will be used as validation data points.

  Baseline (at diagnosis of short cervix), third trimester (approximately 26-30 weeks)

Secondary Outcomes (1)

• Number of participants with spontaneous preterm birth

  Pregnancy duration, an average of up to 40 weeks

Study Arms (2)

Pessary and Progesterone

EXPERIMENTAL

Women already receiving a pessary in addition to the standard progesterone through the TOPS trial will undergo ultrasound imaging and cervical speculum examination for information collection.

Procedure: Ultrasound imaging; Procedure: Cervical speculum examination

Progesterone only

PLACEBO COMPARATOR

Women already receiving the standard progesterone only will undergo ultrasound imaging and cervical speculum examination for information collection.

Procedure: Ultrasound imaging; Procedure: Cervical speculum examination

Interventions

Ultrasound imaging PROCEDURE

This standard of care procedure is being done for research purposes and used to collect information and measure the maternal and fetal anatomy.

Also known as: Sonography

Pessary and Progesterone; Progesterone only

Cervical speculum examination PROCEDURE

This standard of care procedure is being done for research purposes and used to collect tissue and measure the strength and stiffness of cervix.

Also known as: Cervical aspiration

Pessary and Progesterone; Progesterone only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton gestation.
• Twin gestation reduced to singleton either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age.
• Higher order multifetal gestations reduced to singletons are not eligible.
• Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age.
• Cervical length on transvaginal examination of less than or equal to 20 mm within 10 days prior to randomization by a study certified sonographer. There is no lower cervical length threshold.

You may not qualify if:

• Women who are ineligible for the TOPS trial.

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (23)

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• 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.

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• 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.

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• 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

• 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

• 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

• 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.

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• 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

• 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

• Ginsberg Y, Goldstein I, Lowenstein L, Weiner Z. Measurements of the lower uterine segment during gestation. J Clin Ultrasound. 2013 May;41(4):214-7. doi: 10.1002/jcu.22023. Epub 2013 Mar 16.

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• Durnwald CP, Mercer BM. Myometrial thickness according to uterine site, gestational age and prior cesarean delivery. J Matern Fetal Neonatal Med. 2008 Apr;21(4):247-50. doi: 10.1080/14767050801926709.

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• Buhimschi CS, Buhimschi IA, Norwitz ER, Sfakianaki AK, Hamar B, Copel JA, Saade GR, Weiner CP. Sonographic myometrial thickness predicts the latency interval of women with preterm premature rupture of the membranes and oligohydramnios. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):762-70. doi: 10.1016/j.ajog.2005.01.053.

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MeSH Terms

Conditions

Premature Birth

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Kristin Myers, PhD

  Associate Professor of Mechanical Engineering

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Mechanical Engineering

Model Details: The two arms are not randomized under this sub study but carried over from the existing TOPS trial.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 6, 2019
• Study Start: June 5, 2017
• Primary Completion: January 23, 2021
• Study Completion: January 23, 2021
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

US (1)