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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02827604
Acronym
SALUTARY
Enrollment
30
Registered
2016-07-11
Start date
2015-02-28
Completion date
2016-12-31
Last updated
2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar; Previous Cesarean Section

Keywords

Caesarean section, lower uterine segment, sonography

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.

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.

Interventions

None listed

Sponsors

Martin-Luther-Universität Halle-Wittenberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment Iintraoperative - just bevore the uterotomyBland-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)

Secondary

MeasureTime frameDescription
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIAintraoperative - just bevore the uterotomyBland-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)
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIBintraoperative - just bevore the uterotomyBland-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)
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IICintraoperative - just bevore the uterotomyBland-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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026