An interventional study of Purse string closure technique and Continuously locked closure technique in Cesarean Section; Complications, Placenta Previa and Placenta Accreta, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Uterine Kerr incision will be closed with purse string suture.
Procedure: Purse string closure technique
Uterine Kerr incision will be closed with continuously locked closure technique.
Procedure: Continuously locked closure technique
Uterine incision will be closed with purse string closure technique.
Also known as: Uterine incision in C/S
Uterine incision will be closed with continuously locked closure technique
Also known as: Uterine incision in C/S
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
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
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
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
| Milestone | Purse String Closure Technique | Continuously Locked Closure Technique |
|---|---|---|
| Started | 84 | 84 |
| Completed | 51 | 65 |
| Not completed | 33 | 19 |
| Withdrew: Lost to follow-up | 29 | 16 |
| Withdrew: Exclusion due to expanded kerr incision | 4 | 3 |
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.
| Participants | Purse String Closure Technique | Continuously Locked Closure Technique |
|---|---|---|
| Subsequent pregnancy without low lying placenta, placenta previa marginalis and totalis | 18 | 17 |
| Low lying placenta | 0 | 3 |
| Placenta previa marginalis | 0 | 2 |
| Placenta previa totalis | 0 | 1 |
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.
| Participants | Purse String Closure Technique | Continuously Locked Closure Technique |
|---|---|---|
| No placental adhesion (insertion) anomaly | 18 | 23 |
| Placental adhesion (insertion) anomaly | 0 | 0 |
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.
| Participants | Purse String Closure Technique | Continuously Locked Closure Technique |
|---|---|---|
| Without uterine rupture (incomplete or complete, dehiscence of uterine incision) | 18 | 23 |
| With uterine rupture (incomplete or complete, dehiscence of uterine incision) | 0 | 0 |
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.
| Participants | Purse String Closure Technique | Continuously Locked Closure Technique |
|---|---|---|
| No intra-abdominal adhesions | 16 | 17 |
| Filmy intra-abdominal adhesions | 2 | 3 |
| Dense intra-abdominal adhesions | 0 | 3 |
Collected over 6 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Purse String Closure Technique | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Continuously Locked Closure Technique | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(Years) | Purse String Closure Technique | Continuously Locked Closure Technique | Total |
|---|---|---|---|
| Mean | 29.6 ± 5.0 | 28.5 ± 5.3 | 29.05 ± 5.15 |
| Sex: Female, Male(Participants) | Purse String Closure Technique | Continuously Locked Closure Technique | Total |
|---|---|---|---|
| Female | 51 | 65 | 116 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Purse String Closure Technique | Continuously Locked Closure Technique | Total |
|---|---|---|---|
| Turkey | 51 | 65 | 116 |
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Dr. Lutfi Kirdar Kartal Training and Research Hospital