Clinical trial NCT02827604: Preoperative and Intraoperative Sonographic Assessment of Lower Uterine Segment Thickness at Term in Women With Previous Cesarean Delivery - a Ultrasound Method Comparison Study
Official title: Präoperative Und Intraoperative Sonografische Beurteilung Des Unteren Uterinsegmentes im Rahmen Der Re-Sectio Caesarea - Eine Ultraschall- Methoden-Vergleichsstudie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scar; Previous Cesarean Section
Keywords: Caesarean section
lower uterine segment
sonography
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with pregnancies after previous cesarean section who referre to the tertiary referral care center.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I
timeFrame: intraoperative - just bevore the uterotomy
Secondary outcomes:
measure: Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIA
timeFrame: intraoperative - just bevore the uterotomy
measure: Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIB
timeFrame: intraoperative - just bevore the uterotomy
measure: Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIC
timeFrame: intraoperative - just bevore the uterotomy
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
state: ST
Study officials:
affiliation: Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
name: Gregor Seliger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
name: Michael Tchirikov, MD
role: STUDY_CHAIR
References:
citation: 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.