Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency
NCT ID: NCT03039803
Last Updated: 2018-08-23
Study Results
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Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-01-31
2019-09-30
Brief Summary
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The prevalence of lower-segment uterine scar deficiency has previously been described as 63%. One recent systematic review and meta analysis investigated closure techniques of low transverse cesarean. No significant difference in risk of uterine scar defect comparing single layer versus double layer closure could be detected (RR 0.53), whereas in women with single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However, the authors do conclude that data is insufficient to determine the risk of uterine rupture, dehiscence or gynecological outcomes due to insufficient power of available studies. A recently published Randomized Controlled Trial concluded that double-layer closure with unlocked first layer showed a better scar healing than locked single layer.
The investigators main objective is to identify if single-layer suture of the uterus during cesarean section results in a higher rate of cesarean scar deficiency than double-layer suture.
Interventions
Single- layer versus double- layer uterine closure Two different techniques of uterine closure in cesarean section will be compared: single- layer versus double- layer continuous uterotomy suture.
Standardized transvaginal sonography
Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound machine used for all examinations is GE Voluson E10.
Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no).
Secondary outcome: Myometrial thickness at the site of uterine scar (mm).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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single-layer continuous uterotomy suture
Single-layer continuous uterotomy suture
uterine closure during cesarean section
double-layer continuous uterotomy suture
double-layer continuous uterotomy suture
uterine closure during cesarean section
Interventions
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uterine closure during cesarean section
Eligibility Criteria
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Inclusion Criteria
* Scheduled cesarean section at Department of Obstetrics and Gynecology, Medical University of Vienna
* Age ≥ 18 years
* Informed Consent
* Cesarean section at ≥ 37+0 weeks of gestation
Exclusion Criteria
* Emergency cesarean section
* Cesarean section \< 37+0 weeks of gestation
* Corporal incision during cesarean section
* Diseases which favor wound healing disruptions (e.g. chronic inflammatory diseases)
* Uterine anatomic anomalies
* BMI \> 35kg/m2
* Placenta previa
18 Years
50 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Samir Helmy
Dr.
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Ofili-Yebovi D, Ben-Nagi J, Sawyer E, Yazbek J, Lee C, Gonzalez J, Jurkovic D. Deficient lower-segment Cesarean section scars: prevalence and risk factors. Ultrasound Obstet Gynecol. 2008 Jan;31(1):72-7. doi: 10.1002/uog.5200.
Roberge S, Demers S, Berghella V, Chaillet N, Moore L, Bujold E. Impact of single- vs double-layer closure on adverse outcomes and uterine scar defect: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Nov;211(5):453-60. doi: 10.1016/j.ajog.2014.06.014. Epub 2014 Jun 6.
Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92.
Gilliam M, Rosenberg D, Davis F. The likelihood of placenta previa with greater number of cesarean deliveries and higher parity. Obstet Gynecol. 2002 Jun;99(6):976-80. doi: 10.1016/s0029-7844(02)02002-1.
Miller DA, Chollet JA, Goodwin TM. Clinical risk factors for placenta previa-placenta accreta. Am J Obstet Gynecol. 1997 Jul;177(1):210-4. doi: 10.1016/s0002-9378(97)70463-0.
Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
Thurn L, Lindqvist PG, Jakobsson M, Colmorn LB, Klungsoyr K, Bjarnadottir RI, Tapper AM, Bordahl PE, Gottvall K, Petersen KB, Krebs L, Gissler M, Langhoff-Roos J, Kallen K. Abnormally invasive placenta-prevalence, risk factors and antenatal suspicion: results from a large population-based pregnancy cohort study in the Nordic countries. BJOG. 2016 Jul;123(8):1348-55. doi: 10.1111/1471-0528.13547. Epub 2015 Jul 29.
Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.
Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev. 2014 Jul 22;2014(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.
Other Identifiers
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1642/2016
Identifier Type: -
Identifier Source: org_study_id
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