Prediction of Spontaneous Preterm Birth by Cervical Elastogram

NCT03601195 | Unknown

• 1 other identifier: CRE 2017.265
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Preterm birth is the leading cause of perinatal morbidity and mortality in multiple pregnancies. The medical and educational expenditure and lost productivity associated with preterm birth is very high. Sonoelastography is a new ultrasound technology which has enabled the measurement of tissue stiffness and it has been widely applied in assessment of breast lump and liver cirrhosis. Sonoelastography is potentially useful for the objective assessment of cervical consistency which could be related to risk of preterm birth. Objective: To assess the cervical consistency by shear wave elastography in prediction of preterm birth in multiple pregnancies. Setting: This is a prospective non-interventional observational study. Subjects: Chinese women carrying multiple pregnancies attending antenatal visit are invited to join the study. Method: Demographic data and antenatal history will be obtained. Transvaginal scan for the cervix will be performed by a trained researcher or obstetrician for the assessment of cervical consistency, cervical length, posterior cervical angle and fetal viability. The measurements will be repeated during 5 antenatal visits or separate study visits at 11-15, 16-19, 20-23, 24-27 and 28-32 weeks of gestation. At the end of pregnancy, the delivery data and neonatal outcome will be collected. Sample Size: The risk of preterm birth \<34 weeks in twin pregnancies is approximately 20%. A sample size of 120 was determined as being sufficient to test the diagnostic performance of cervical elasticity in mid trimester assuming that the risk of preterm delivery \<34 weeks vs \>34 weeks is 1:5 and that cervical elasticity area under curve (AUC) of the receiver operating characteristics (ROC) curve was 0.7, with 80% power and alpha of 5%. Data Analysis: Changes in the cervical elastography will be compared using the Student paired two-tailed t test, and in the case of unequal standard deviation (SD), using a Wilcoxon signed-rank paired two-tailed test. For comparison of frequencies, Chi-square test, or a two-sided Fisher exact test will be used where appropriate. Linear regression will be used to assess the correlations. The level of statistical significance is set at p\<0.05 (two-sided).

Conditions

Preterm Birth

Keywords

Sonoelastography

Outcome Measures

Primary Outcomes (1)

• The association of cervical consistency in mid trimester with spontaneous preterm birth in women carrying multiple pregnancies

  Cervical consistency will be measured by sonoelastography in term of kilopascals.

  Between 11 and 32 weeks of gestation

Secondary Outcomes (1)

• The change in cervical consistency during pregnancy in women carrying multiple pregnancies

  Between 11 and 32 weeks of gestation

Study Arms (1)

Subjects

Chinese women carrying multiple pregnancies

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese women carrying multiple pregnancies.

You may qualify if:

• Chinese women carrying multiple pregnancies attending antenatal visit are invited to join the study.

You may not qualify if:

• an age of less than 18 years;
• non-Chinese;
• inability to provide consent;
• refuse to join.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Tak Yeung LEUNG

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwun Yue Yvonne CHENG

CONTACT

852-35052582; yvonnecheng@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: July 26, 2018
• Study Start: July 3, 2017
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

HK (1)