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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03851003
Enrollment
130
Registered
2019-02-22
Start date
2019-05-01
Completion date
2022-07-01
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Wound Disruption

Keywords

cesarean section, niche, uterine scar defect

Brief 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.

Detailed 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 ).

Interventions

PROCEDUREEndometrial suturing

Suturing will include endometrium during cesarean incision repair

PROCEDURENon- endometrial suturing

Suturing will not include endometrium during cesarean incision repair

All women will be invited six month post operation for vaginal sonographic evaluation of the uterine scar

OTHERQuestionnaire

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

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Women will not know which arm they were allocated to

Intervention model description

Uterine incision repair will include or exclude suturing of the endometrium

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

Inclusion criteria

* Term pregnancy (≥37 weeks of gestation) * Elective CS

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with uterine scar defect six month post cesarean sectionUntil six month post cesarean section, and through study completion, an average of 1 yearUterine scar defect with residual myometrium thickness of less then 2.5 mm

Secondary

MeasureTime frameDescription
SpottingThrough study completion, an average of 1 yearThe rate of spotting complains since operation reported by the women
Abdominal painThrough study completion, an average of 1 yearThe 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).

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026