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NCT02283567 Clinical Trial

The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies

Pregnancy Clinical Trial

— DEU  

Official title:
The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02283567
Other study ID # 0152-14-MMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 27, 2014
Last updated September 22, 2015
Start date November 2015
Est. completion date November 2016

Study information
Verified date September 2015
Source Meir Medical Center
Contact Rami Aviram, MD
Phone 972544944862
Email rami.aviram@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The investigators aim to compare elasticity of the uterine cervix in singleton and twin pregnancies of similar gestational age.

Description:

Softening of the uterine cervix occurs during pregnancy.There is a possibility that this process occurs earlier in twin versus singleton pregnancies.The softening of the cervix is reflected by the level of its elasticity which can be measured sonoelastographically. A two dimension image of the cervix is obtained in the midsagittal section and the length is noted. A 2nd sonoelastography image is obtained before pressure is applied with the transducer in the area of the internal os and a third sonoelastography image is obtained until no more shortening of the anterior-posterior diameter is observed.Elastography measurements of the internal os are performed using a color map: red (soft), yellow (medium soft), blue (medium hard) and purple (hard) before and after the application of strain.The change between the color maps before and after strain application in singleton pregnancies will be compared to the change in twin pregnancies of similar gestational age.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 44 Years
Eligibility Inclusion Criteria:

- Low risk singleton and twin pregnancies

Exclusion Criteria:

- Patients with pregnancy complications

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of elasticity levels in singleton and twin pregnancies (Elastographic measurements of the internal os) 6 months Yes
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