Single Layer With Unlocked Sutures Versus Double Layer Closure of Cesarean Incision and the Risk of Niche Development

Kafrelsheikh University

Status: Completed

Conditions: Unlocked Sutures; Cesarean Incision; Single Layer; Niche Development; Double Layer Closure

Treatments: Procedure: Double layer unlocked sutures; Procedure: Single layer unlocked sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT07554001

KFSIRB200-106

Details and patient eligibility

About

This study aimed to compare the development of the uterine niche after single and double closure of cesarean incision.

Full description

One of the most performed major surgeries worldwide is a cesarean section (CS), and CS rates are rising. These long-term complications are associated with an anatomical defect of the myometrium due to impaired healing of the incision in the uterus, a so-called uterine niche or cesarean scar defect, and with this increased rate of cesarean delivary the development of uterine niche has also increased In 50-70% of patients after cesarean section.

The classification of niche was based on the measurement of the depth, base of the isthmocele and on calculation of its triangular area. This allowed to classify the uterine niches after cesarean section according to the size of its area.

Enrollment: 366 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Women who undergo first elective cesarean section (CS).

Exclusion criteria

• Women with a previous CS
• Inadequate possibility for counselling (e.g. indication for CS without being informed about the study previously, women in severe pain without adequate therapy
• previous major uterine surgery (e.g. laparoscopic or laparotomy fibroid resection, septum resection), Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro salpinx, uterine anomaly
• Placenta increta or percreta during the current pregnancy
• ≥ Three foetuses during the current pregnancy.
• Placenta previa
• Twins

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

366 participants in 2 patient groups

Group I

Experimental group

Description:

Patients underwent uterine scar closure by single layer unlocked sutures.

Treatment:

Procedure: Single layer unlocked sutures

Group II

Experimental group

Description:

Patients underwent uterine scar closure by double layer unlocked sutures.

Treatment:

Procedure: Double layer unlocked sutures