Scar; Previous Cesarean Section Clinical Trial
— SALUTARYOfficial title:
Präoperative Und Intraoperative Sonografische Beurteilung Des Unteren Uterinsegmentes im Rahmen Der Re-Sectio Caesarea - Eine Ultraschall- Methoden-Vergleichsstudie
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg | Halle (Saale) | ST |
Lead Sponsor | Collaborator |
---|---|
Martin-Luther-Universität Halle-Wittenberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIA | 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 | No |
Secondary | Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIB | 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 | No |
Secondary | Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIC | 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 | No |
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