NCT02827604

Brief Summary

This prospective, clinical, observational study compares preoperative and intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section. It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.

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 2, 2016

Completed
9 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 2, 2016

Last Update Submit

January 4, 2017

Conditions

Scar; Previous Cesarean Section

Keywords

Caesarean sectionlower uterine segmentsonography

Outcome Measures

Primary Outcomes (1)

  • Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I

    Bland-Altman-Plot (mean versus difference) of Method A) Preoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with transabdominal (linear ultrasound probe) and with transvaginal sonography (vaginal ultrasound probe) with the lowest value (thinnest area) being retained AND Method B) Intraoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with intraoperative sonography after preparation of lower uterine segment (linear ultrasound probe)

    intraoperative - just bevore the uterotomy

Secondary Outcomes (3)

  • Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIA

    intraoperative - just bevore the uterotomy

  • Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIB

    intraoperative - just bevore the uterotomy

  • Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIC

    intraoperative - just bevore the uterotomy

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.

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 (1)

  • Seliger G, Chaoui K, Lautenschlager C, Riemer M, Tchirikov M. Technique of sonographic assessment of lower uterine segment in women with previous cesarean delivery: a prospective, pre/intraoperative comparative ultrasound study. Arch Gynecol Obstet. 2018 Aug;298(2):297-306. doi: 10.1007/s00404-018-4805-6. Epub 2018 Jun 8.

    PMID: 29948165DERIVED

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 2, 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)