Cesarean Section Clinical Trial
Official title:
Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency: A Randomized Controlled Trial
NCT number | NCT03039803 |
Other study ID # | 1642/2016 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | September 2019 |
In recent decades, the rate of cesarean section delivery has steadily increased worldwide
ranging at 30% of deliveries, thus long-term risks after cesarean section need to be
evaluated. Postoperative risks include, among others, uterine scar rupture and placental
complications such as placenta previa and accreta- complications, which are possibly
associated with uterine scar dehiscence.
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).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - First cesarean section - 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: - Previous cesarean section - 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92. — View Citation
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;(7):CD004732. doi: 10.1002/14651858.CD004732.pub3. Review. — View Citation
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. — View Citation
Miller DA, Chollet JA, Goodwin TM. Clinical risk factors for placenta previa-placenta accreta. Am J Obstet Gynecol. 1997 Jul;177(1):210-4. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-68. doi: 10.1097/AOG.0000000000001005. Review. — View Citation
Thurn L, Lindqvist PG, Jakobsson M, Colmorn LB, Klungsoyr K, Bjarnadóttir RI, Tapper AM, Børdahl PE, Gottvall K, Petersen KB, Krebs L, Gissler M, Langhoff-Roos J, Källen 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The presence or absence of a CS scar pregnancy in a consecutive pregnancy | up to 25 years | ||
Other | Occurence of uterine rupture in a consecutive pregnancy | up to 25 years | ||
Other | CS scar deficiency visualized in transvaginal ultrasound (yes/no) in early pregnancy in a consecutive pregnancy | up to 25 years | ||
Primary | Cesarean section (CS) scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no). | 3 months | ||
Secondary | Myometrial thickness at the site of uterine scar (mm). | 3 months |
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