Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency

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

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).

Study Overview

• Status: Unknown
• Conditions: Cesarean Section; Transvaginal Ultrasound; Uterine Scar Deficiency; Myometrial Thickness; Single-layer Continuous Uterotomy Suture; Double-layer Continuous Uterotomy Suture
• Intervention / Treatment: Procedure: uterine closure during cesarean section

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Koch, Dr.; Phone Number: 0043 1 40400 29150; Email: marianne.koch@meduniwien.ac.at
• Study Contact Backup: Name: Samir Helmy-Bader, Dr.; Phone Number: 0043 1 40400 29150; Email: samir.helmy@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Contact: Samir Helmy, Ass.Prof.; Phone Number: +4314040029150; Email: samir.helmy@meduniwien.ac.at
    • Contact: Marianne Koch, Dr.; Phone Number: +4314040029150; Email: marianne.koch@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single-layer continuous uterotomy suture; Single-layer continuous uterotomy suture	Procedure: uterine closure during cesarean section
Active Comparator: double-layer continuous uterotomy suture	Procedure: uterine closure during cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cesarean section (CS) scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no).	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Myometrial thickness at the site of uterine scar (mm).	3 months

Other Outcome Measures

Outcome Measure	Time Frame
The presence or absence of a CS scar pregnancy in a consecutive pregnancy	up to 25 years
Occurence of uterine rupture in a consecutive pregnancy	up to 25 years
CS scar deficiency visualized in transvaginal ultrasound (yes/no) in early pregnancy in a consecutive pregnancy	up to 25 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Publications and helpful links

General Publications

• Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
• 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.
• 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;(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1642/2016