Trials / Completed
CompletedNCT04198324
Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 170 (actual)
- Sponsor
- Kocaeli University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.
Detailed description
Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Closure of the uterus with endometrium at the time of cesarean | Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium. |
| PROCEDURE | Closure of the uterus without endometrium at the time of cesarean | Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium. |
Timeline
- Start date
- 2019-12-16
- Primary completion
- 2020-12-14
- Completion
- 2020-12-14
- First posted
- 2019-12-13
- Last updated
- 2020-12-16
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04198324. Inclusion in this directory is not an endorsement.