N/A
N=168
Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
Cesarean Section Complications
Bottom Line
View on ClinicalTrials.gov: NCT01287611 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Cesarean Scar Defect in the Uterine Incisional Line — 12; 39 participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Purse string closure technique (Procedure); Continuously locked closure technique (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cesarean Scar Defect in the Uterine Incisional Line |
12; 39 | 0.0001 sig |
| SECONDARY Length of Uterine Incision After Suturing |
3.7; 8.5 | 0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Singleton pregnancy
- Term (> 37 weeks) pregnancy
- Cervical dilatation 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
Data sourced from ClinicalTrials.gov (NCT01287611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.