Cesarean Section; Complications, Placenta Accreta, Placenta Previa
Conditions
Keywords
Cesarean section, Kerr incision, Purse string suturing in CS, Continuous locked suturing in CS
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. Women will be followed for a subsequent pregnancy in the next average 6 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.
Interventions
PROCEDUREPurse string closure technique
Uterine incision will be closed with purse string closure technique.
Uterine incision will be closed with continuously locked closure technique
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 CS * 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 |
|---|---|---|
| Placenta Previa | Subsequent pregnancy within next average 6 years | It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Placenta Insertion Anomalies | Subsequent pregnancy within next average 6 years | It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. |
| Uterine Rupture | Subsequent pregnancy within next average 6 years | It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. |
| Intra-abdominal Adhesions | Up to average 6 years | It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Purse String Closure Technique Uterine Kerr incision will be closed with purse string suture.
Purse string closure technique: Uterine incision will be closed with purse string closure technique. | 51 |
| Continuously Locked Closure Technique Uterine Kerr incision will be closed with continuously locked closure technique.
Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique | 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 | 0 / 18 | 0 / 23 |
| other Total, other adverse events | 0 / 18 | 0 / 23 |
| serious Total, serious adverse events | 0 / 18 | 0 / 23 |
Outcome results
Primary
Placenta Previa
It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Time frame: Subsequent pregnancy within next average 6 years
Population: Eighteen of 51 patients in the study group (purse string) became pregnant. Of the 18 patients in the study group, pregnancy was terminated by cesarean section without low lying placenta, placenta previa marginalis and placenta previa totalis. Of the 65 patients in the control group, 23 became pregnant. Three of them developed low lying placenta, two developed placenta previa marginalis, and one developed placenta previa totalis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Purse String Closure Technique | Placenta Previa | Subsequent pregnancy without low lying placenta, placenta previa marginalis and totalis | 18 Participants |
| Purse String Closure Technique | Placenta Previa | Placenta previa marginalis | 0 Participants |
| Purse String Closure Technique | Placenta Previa | Low lying placenta | 0 Participants |
| Purse String Closure Technique | Placenta Previa | Placenta previa totalis | 0 Participants |
| Continuously Locked Closure Technique | Placenta Previa | Placenta previa totalis | 1 Participants |
| Continuously Locked Closure Technique | Placenta Previa | Subsequent pregnancy without low lying placenta, placenta previa marginalis and totalis | 17 Participants |
| Continuously Locked Closure Technique | Placenta Previa | Low lying placenta | 3 Participants |
| Continuously Locked Closure Technique | Placenta Previa | Placenta previa marginalis | 2 Participants |
Secondary
Intra-abdominal Adhesions
It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Time frame: Up to average 6 years
Population: Intra-abdominal filmy adhesion was detected in 2 of 18 pregnant cases in the Turan technique (purse string) group and intra-abdominal adhesion developed in 6 of 23 cases who became pregnant in the control (Continuously locked closure technique) group. Three of them were filmy and the other three were dense adhesions involving the omentum and intestine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Purse String Closure Technique | Intra-abdominal Adhesions | No intra-abdominal adhesions | 16 Participants |
| Purse String Closure Technique | Intra-abdominal Adhesions | Filmy intra-abdominal adhesions | 2 Participants |
| Purse String Closure Technique | Intra-abdominal Adhesions | Dense intra-abdominal adhesions | 0 Participants |
| Continuously Locked Closure Technique | Intra-abdominal Adhesions | Filmy intra-abdominal adhesions | 3 Participants |
| Continuously Locked Closure Technique | Intra-abdominal Adhesions | No intra-abdominal adhesions | 17 Participants |
| Continuously Locked Closure Technique | Intra-abdominal Adhesions | Dense intra-abdominal adhesions | 3 Participants |
Secondary
Placenta Insertion Anomalies
It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Time frame: Subsequent pregnancy within next average 6 years
Population: Placental adhesion (insertion) anomaly did not develop in any of the 18 cases who became pregnant in the Turan technique (purse string) group and in none of the 23 cases who became pregnant in the control (continuously locked closure) group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Purse String Closure Technique | Placenta Insertion Anomalies | No placental adhesion (insertion) anomaly | 18 Participants |
| Purse String Closure Technique | Placenta Insertion Anomalies | Placental adhesion (insertion) anomaly | 0 Participants |
| Continuously Locked Closure Technique | Placenta Insertion Anomalies | No placental adhesion (insertion) anomaly | 23 Participants |
| Continuously Locked Closure Technique | Placenta Insertion Anomalies | Placental adhesion (insertion) anomaly | 0 Participants |
Secondary
Uterine Rupture
It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Time frame: Subsequent pregnancy within next average 6 years
Population: Uterine rupture (incomplete or complete, dehiscence of uterine incision) did not develop in any of the 18 cases who became pregnant in the Turan technique (Purse string closure technique) group and in none of the 23 cases who became pregnant in the control (continuously locked closure technique) group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Purse String Closure Technique | Uterine Rupture | Without uterine rupture (incomplete or complete, dehiscence of uterine incision) | 18 Participants |
| Purse String Closure Technique | Uterine Rupture | With uterine rupture (incomplete or complete, dehiscence of uterine incision) | 0 Participants |
| Continuously Locked Closure Technique | Uterine Rupture | Without uterine rupture (incomplete or complete, dehiscence of uterine incision) | 23 Participants |
| Continuously Locked Closure Technique | Uterine Rupture | With uterine rupture (incomplete or complete, dehiscence of uterine incision) | 0 Participants |