N/A
N=282
Single or Double-layer Uterine Closure Techniques
Uterine Scar · Cesarean Section Complications · Cesarean Section; Dehiscence
Bottom Line
View on ClinicalTrials.gov: NCT03629028 ↗Enrolled (actual)
282
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Niche Visualized by Saline Infusion Sonography — 40; 53; 25; 23 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Residual myometrium thickness (Diagnostic_test); Niche Presence (Diagnostic_test); Adjacent myometrium thickness (Diagnostic_test); Niche Measurements (depth of niche, width of niche, length of niche) (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Safak Baran Yilmaz
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Niche Visualized by Saline Infusion Sonography |
40; 53; 25; 23 | 0.05 |
| PRIMARY Median Depth of Niche |
1.7; 2.4 | — |
| PRIMARY Median Length of Niche |
3.5; 3.8 | — |
| PRIMARY Median Width of Niche in Transverse Plane |
2.8; 4 | — |
| SECONDARY Residual Myometrium Thickness - 6 to 9 Months |
9.6; 9.4 | — |
| SECONDARY Adjacent Myometrium Thickness |
12.1; 12 | — |
Summary
There are different surgical techniques of uterine closure during cesarean. A growing data has suggested that the closure technique has an effect on uterine scar healing. Residual myometrium thickness and uterine scar defect (niche) development seems to be related to the single or double layer closure of uterus. In that study, investigators will search for the effect of single or double layer closure of uterus during cesarean on the uterine scar defect.
Eligibility Criteria
Inclusion Criteria
- Primary cesarean, singleton pregnancy,
Exclusion Criteria
- Multiple pregnancy, History of any uterine surgery, wound healing diseases (insulin dependent diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease)
Data sourced from ClinicalTrials.gov (NCT03629028). 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.