The Influence of Endometrial Suturing on the Risk of Uterine Scar Defect

Cesarean Wound Disruption Clinical Trial

Official title:

The Influence of Endometrial Suturing During Cesarean Section on the Risk to Develop Uterine Scar Defect: A Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851003
• Other study ID #: 5822-18-SMC
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Caesarean section (CS) is the commonest major operation performed on women worldwide with progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar defect have been increasing. Given the association between uterine scar defect and gynecological symptoms, obstetric complications and potentially with subfertility, it is important to elucidate the etiology in order to develop preventive strategies. Surgical technique of uterine incision closure seems to be the most important determinant of defect formation. The aim of this prospective randomized study is to evaluate specifically the influence of inclusion versus exclusion of the endometrium during suturing the uterine incision on the risk to develop uterine scar defect.

Description:

Caesarean section (CS) is the commonest major operation performed on women worldwide with progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar defect have been increasing. Common gynecological complains include chronic pelvic pain, dyspareunia, dysmenorrhea and postmenstrual spotting and infertility. Obstetric sequelae seem to be increasing such as cesarean scar ectopic pregnancy, placenta previa, and placenta accrete, all associated with major maternal morbidity and even mortality. Given the association between uterine scar defect and gynecological symptoms, obstetric complications and potentially with subfertility, it is important to elucidate the etiology in order to develop preventive strategies. Probable risk factors suggested are single-layer myometrium closure, multiple CSs and uterine retroflexion, however, surgical technique of uterine incision closure seems to be the most important determinant of defect formation. It is proposed that continuous, non-locking absorbable sutures in two layers, without including much of decidua and without undue tight (constricting) pulling of sutures are likely to result in good healing of uterine scar. The aim of this prospective randomized study is to evaluate specifically the influence of inclusion versus exclusion of the endometrium during suturing the uterine incision on the risk to develop uterine scar defect. Material and Methods Prospective randomized single blinded study conducted in a single tertiary center. All women at term (≥37 weeks of gestation) with singleton pregnancy that are about to go threw cesarean section attending the pre- operative clinics, will be offered to participate in the study. After signing informed consent, women will be block randomized for one of two groups: A- uterine incision repair including suturing of the endometrium, B - uterine incision repair without including the endometrium. All operation will be performed by a single highly skilled obstetrician. All other stages of operations will be similar in both of the groups including: low segment incision, delivery of the fetus and the placenta, uterine revision, intraperitoneal uterine repair, use of stratafix thread in double layer suturing. Operative and post operative data will be collected from the medical files including: operation duration, estimated blood loss, operation complications ( hypotension, bladder gut or vascular perforation ) , post operative complications ( hemorrhage, endometritis, vascular - thromboembolic event, ileus ). All women will be invited to the gynecologic clinics six month post operation for vaginal sonographic evaluation of the uterine scar and for filling questionnaire concerning possibility of uterine scar defect ( spotting, pelvic pain, fertility abnormalities ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Term pregnancy (=37 weeks of gestation)
• Elective CS

Exclusion Criteria:

• Uterine scar
• Thrombophilia
• Dysmorphic uterus
• Connective tissue disorder

Related Conditions & MeSH terms

• Cesarean Wound Disruption

Intervention

Procedure:
• Endometrial suturing
Suturing will include endometrium during cesarean incision repair
• Non- endometrial suturing
Suturing will not include endometrium during cesarean incision repair

Device:
• Vaginal ultrasonography
All women will be invited six month post operation for vaginal sonographic evaluation of the uterine scar

Other:
• Questionnaire
All women will be invited six month post operation for filling questionnaire concerning possibility of uterine scar defect ( spotting, pelvic pain, fertility abnormalities )

Locations

Country	Name	City	State
Israel	Dr. Aya Mohr-Sasson	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Mathai M, Hofmeyr GJ, Mathai NE. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2013 May 31;(5):CD004453. doi: 10.1002/14651858.CD004453.pub3. — View Citation

Sholapurkar SL. Etiology of Cesarean Uterine Scar Defect (Niche): Detailed Critical Analysis of Hypotheses and Prevention Strategies and Peritoneal Closure Debate. J Clin Med Res. 2018 Mar;10(3):166-173. doi: 10.14740/jocmr3271w. Epub 2018 Jan 26. — View Citation

Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5. — View Citation

van der Voet LF, Bij de Vaate AM, Veersema S, Brolmann HA, Huirne JA. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding. BJOG. 2014 Jan;121(2): — View Citation

Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Se — View Citation

Wang CB, Chiu WW, Lee CY, Sun YL, Lin YH, Tseng CJ. Cesarean scar defect: correlation between Cesarean section number, defect size, clinical symptoms and uterine position. Ultrasound Obstet Gynecol. 2009 Jul;34(1):85-9. doi: 10.1002/uog.6405. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with uterine scar defect six month post cesarean section	Uterine scar defect with residual myometrium thickness of less then 2.5 mm	Until six month post cesarean section, and through study completion, an average of 1 year
Secondary	Spotting	The rate of spotting complains since operation reported by the women	Through study completion, an average of 1 year
Secondary	Abdominal pain	The rate of abdominal pain since operation reported by the women and estimated by "The Visual Analogue Scale" (VAS) for the estimation of pain. In this scale, women will be asked to mark the pain that they are experiencing on a 10cm-long horizontal line labeled "no pain" on the far left and "worst pain ever" on the far right. Pain intensity is determined by the length of the line as measured from the left-hand side to the point marked. The following cut points on the pain VAS will be use: no pain (0-0.4 cm), mild pain (0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10 cm).	Through study completion, an average of 1 year