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

NCT ID: NCT02827604

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Scar; Previous Cesarean Section

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role lead

Responsible Party

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Gregor Seliger

Dr. med., chief resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregor Seliger, MD

Role: PRINCIPAL_INVESTIGATOR

Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Michael Tchirikov, MD

Role: STUDY_CHAIR

Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Locations

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Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony-Anhalt, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29948165 (View on PubMed)

Other Identifiers

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SALUTARY

Identifier Type: -

Identifier Source: org_study_id

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