NCT02827591

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

July 3, 2016

Last Update Submit

January 4, 2017

Conditions

Scar; Previous Cesarean Section

Keywords

repeat cesarean sectionlower uterine segmentquantitative sonography

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Difference - In vivo Ultrasonic Elastic Modulus versus in vitro tensile property measurements of LUS

    within 1 hour after Cesarean Section

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with pregnancies after previous cesarean section who referre to the tertiary referral care center. Pregnant women have been scheduled for a consecutive Caesarean section.

You may qualify if:

  • 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

You may not qualify if:

  • emergency caesarean section
  • \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony-Anhalt, 06120, Germany

Location

Related Publications (2)

  • 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.

    PMID: 23090468BACKGROUND

  • 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. doi: 10.1016/j.ajog.2005.07.048.

    PMID: 16458657BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Scar tissue is placed in formalin and embedded in paraffin.

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregor Seliger, MD

    Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

  • Michael Tchirikov, MD

    Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med., chief resident

Study Record Dates

First Submitted

July 3, 2016

First Posted

July 11, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)