Assessing the Stability of Uterine Scar Tissue in Women With Previous History of Caesarean Section Using Multimodal Analyses of the Lower Uterine Segment Including Quantitative Sonography

Scar; Previous Cesarean Section Clinical Trial

— QUANTUSLUS  

Official title:

Multimodale Beurteilung Der Stabilität Von Uterusnarbengewebe Bei Z.n. Sectio Caesarea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827591
• Other study ID #: QUANTUSLUS
• Status: Completed
• Phase: N/A
• First received: July 3, 2016
• Last updated: January 4, 2017
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

This prospective, clinical, observational trial compares the measured value with quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value with quantitative ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the experimental measurement done in vitro (postoperatively) of lower uterine segment of women who underwent second cesarean section.

Description:

In 1991, 126.297 (15.3%) women delivered by caesarean section in Germany. Since then, the rate of caesarean section increased steadily over the next 20 years, reaching up to 32.2% in 2011. The absolute risk of uterine rupture in vaginal birth after Caesarean section is 1 in 100 deliveries. The risk of perinatal death or the outcome of extremely neurological impairment is 1 in 1000 deliveries.

Statistically more than 300 pregnant women with a prior caesarean delivery visit daily ultrasound departments of german hospitals to investigate the C-section scar before delivery. They have one important question: Is it possible to predict successful trial of labor after cesarean delivery? The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment.

What are the possibilities of additional parameters to examine the stability of uterine scar tissue? Currently, there is no defined cut-off value of scar thickness for the prediction of uterine rupture. It remains questionable whether the thickness of the lower uterine segment is the determinant factor for the stability of the scar and the probability of rupture. However, another important factor is the functional elasticity or the structure of the connective tissue. It has not been further investigated until now (both quantitatively and qualitatively).

Objective of this project: Multimodalities of assessments, including ultrasonography and elastography, validate the accuracy of uterine scar stability in women with previous history of Caesarean section in vitro and in vivo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnancy after previous cesarean section

• pregnancy between 37 0/7 and 42 0/7 weeks of gestation

• primary or secondary indication for cesarean section

• ability to give informed consent in german or english

Exclusion Criteria:

• emergency caesarean section

• <18 years old

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scar; Previous Cesarean Section

Locations

Country	Name	City	State
Germany	Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg	Halle (Saale)	ST

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Pollio F, Staibano S, Mascolo M, Salvatore G, Persico F, De Falco M, Di Lieto A. Uterine dehiscence in term pregnant patients with one previous cesarean delivery: growth factor immunoexpression and collagen content in the scarred lower uterine segment. Am J Obstet Gynecol. 2006 Feb;194(2):527-34. — View Citation

Varner M. Cesarean scar imaging and prediction of subsequent obstetric complications. Clin Obstet Gynecol. 2012 Dec;55(4):988-96. doi: 10.1097/GRF.0b013e318263c699. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vitro Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS	The measured value of lower uterine segment with quantitative ultrasonic Elastic modulus E (kPA) in vitro versus the experimental tensile property measurements of lower uterine segment done in vitro. (Spearman's rank correlation coefficient)	within 1 hour after Cesarean Section	No
Secondary	Difference - In vivo Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS	The measured value of lower uterine segment with quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) in vivo versus the experimental tensile property measurements of lower uterine segment done in vitro (postoperatively). (Spearman's rank correlation coefficient)	within 1 hour after Cesarean Section	No

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