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Completed

NCT Number: NCT07554001

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single layer unlocked sutures

Procedure

Patients underwent uterine scar closure by single layer unlocked sutures.

Double layer unlocked sutures

Procedure

Patients underwent uterine scar closure by double layer unlocked sutures.

Primary outcomes

  1. Assessment of the presence of niche

    Time frame: 6 months after the procedure

    Patient were asked about any symptoms of the niche like post menstrual spotting as brownish discharge for more than two days at the end of menses or spotting more than seven days or inter menstrual blood loss that start after the end of menses or dysmenorrhea and prolonged bleeding

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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