Preoperative and Intraoperative Sonographic Assessment of Lower Uterine Segment Thickness at Term in Women With Previous Cesarean Delivery - a Ultrasound Method Comparison Study (SALUTARY)

January 4, 2017 updated by: Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg

Präoperative Und Intraoperative Sonografische Beurteilung Des Unteren Uterinsegmentes im Rahmen Der Re-Sectio Caesarea - Eine Ultraschall- Methoden-Vergleichsstudie

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.

Study Overview

Status

Completed

Conditions

Detailed 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 [https://www.destatis.de]. 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 [Cunningham et al., 2009].

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? [AQUA-Institut] The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment [Varner et al., 2012].

The measurement technique for lower uterine segment (myometrial) thicknesses in the third trimester have been described by several authors. Using a combination of preoperative transvaginal and transabdominal (linear/convex probe) ultrasound, we compare with intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.

The aim of the present study is to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.

This will allow the investigators to draw conclusions regarding the best method to assessment of lower uterine segment (myometrial) thickness in the third trimester to predict successful trial of labor after cesarean delivery.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • ST
      • Halle (Saale), ST, Germany, 06120
        • Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with pregnancies after previous cesarean section who referre to the tertiary referral care center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I
Time Frame: intraoperative - just bevore the uterotomy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIA
Time Frame: intraoperative - just bevore the uterotomy
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 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
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIB
Time Frame: intraoperative - just bevore the uterotomy
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 (convex ultrasound probe) 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
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIC
Time Frame: intraoperative - just bevore the uterotomy
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 transvaginal sonography (vaginal ultrasound probe) 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

  • Principal Investigator: Gregor Seliger, MD, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
  • Study Chair: Michael Tchirikov, MD, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 2, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SALUTARY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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