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Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

Not Applicable
Completed
Conditions
Placenta Accreta
Cesarean Section; Complications
Placenta Previa
Interventions
Procedure: Purse string closure technique
Procedure: Continuously locked closure technique
Registration Number
NCT01289262
Lead Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
168
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Purse string closure techniquePurse string closure techniqueUterine Kerr incision will be closed with purse string suture.
Continuously locked closure techniqueContinuously locked closure techniqueUterine Kerr incision will be closed with continuously locked closure technique.
Primary Outcome Measures
NameTimeMethod
Placenta PreviaSubsequent 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 Outcome Measures
NameTimeMethod
Placenta Insertion AnomaliesSubsequent 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.

Intra-abdominal AdhesionsUp 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.

Uterine RuptureSubsequent 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.

Trial Locations

Locations (1)

Health Institutes of Turkey ISTANBUL, TURKEY

🇹🇷

Istanbul, Turkey

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