N/A
Completed N=282
Single or Double-layer Uterine Closure Techniques
Uterine Scar · Cesarean Section Complications · Cesarean Section; Dehiscence
Source: ClinicalTrials.gov NCT03629028 ↗
Enrolled (actual)
282
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Number of Participants With Niche Visualized by Saline Infusion Sonography — 40; 53; 25; 23 Participants — p=0.05
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.
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 | — |
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. Informational only — not medical advice.