Cesarean Section Complications
Conditions
Keywords
Cesarean section, Kerr incision, Purse string suturing in C/S, Continuous locked suturing in C/S
Brief summary
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
Detailed description
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision (double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used. The two groups will be compared after 6 weeks in terms of healing, operation time, blood loss, incision size and incisional scar defect( if present). A physician who does not know the method of closure will evaluate incision size by transabdominal and/or transvaginal ultrasound. The length of the incision and myometrial thickness in Kerr incisional line will be measured and recorded in longitudinal and transverse axis separately. If any incisional scar defect is determined it will be measured and recorded also.
Interventions
PROCEDUREPurse string closure technique
Uterine Kerr incision will be closed with purse string suture
Uterine Kerr incision will be closed with continuously locked suturing
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy * Term (\> 37 weeks) pregnancy * Cervical dilatation \< 4 cm * Kerr incision * Age \> 18 years old
Exclusion criteria
* Being in active phase of labor * Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa ) * Having a history of uterine surgery (myomectomy, hysterotomy)other than C/S * Extension of Kerr incision * Multiple pregnancy * Maternal diabetes mellitus * Maternal connective tissue disease * Uterine malformation * Uterine fibroids on Kerr incision line * Chorioamnionitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean Scar Defect in the Uterine Incisional Line | 6 weeks after C/S | A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Uterine Incision After Suturing | 6 weeks after C/S | Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Purse String Closure Technique Purse string closure: Uterine Kerr incision will be closed with purse string suture | 51 |
| Continuously Locked Closure Technique Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing | 65 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion due to expanded Kerr incision | 4 | 3 |
| Overall Study | Lost to Follow-up | 29 | 16 |
Baseline characteristics
| Characteristic | Purse String Closure Technique | Continuously Locked Closure Technique | Total |
|---|---|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 5 | 28.5 years STANDARD_DEVIATION 5.3 | 29.05 years STANDARD_DEVIATION 5.15 |
| Region of Enrollment Turkey | 51 participants | 65 participants | 116 participants |
| Sex: Female, Male Female | 51 Participants | 65 Participants | 116 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 65 |
| serious Total, serious adverse events | 0 / 51 | 0 / 65 |
Outcome results
Primary
Cesarean Scar Defect in the Uterine Incisional Line
A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.
Time frame: 6 weeks after C/S
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Purse String Closure Technique | Cesarean Scar Defect in the Uterine Incisional Line | 12 participants | 4.38 |
| Continuously Locked Closure Technique | Cesarean Scar Defect in the Uterine Incisional Line | 39 participants | 6.11 |
p-value: 0.0001Chi-squared
Secondary
Length of Uterine Incision After Suturing
Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.
Time frame: 6 weeks after C/S
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Purse String Closure Technique | Length of Uterine Incision After Suturing | 3.7 cm | Standard Deviation 0.9 |
| Continuously Locked Closure Technique | Length of Uterine Incision After Suturing | 8.5 cm | Standard Deviation 1.7 |
p-value: 0.001t-test, 2 sided