Trial Outcomes & Findings for Single or Double-layer Uterine Closure Techniques (NCT NCT03629028)
NCT ID: NCT03629028
Last Updated: 2020-05-01
Results Overview
The presence of niche in incision line visualized by saline infusion sonography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
282 participants
Primary outcome timeframe
6 to 9 months
Results posted on
2020-05-01
Participant Flow
Participant milestones
| Measure |
Single Layer
Age:18-45 Years,Only women who underwent cesarean section 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) Uterus will be sutured in locked single layer during cesarean Diagnostic Test: Total myometrium thickness, Residual myometrium thickness, Niche Presence and Measurements in 3D will be evaluated in 6th months by saline infusion sonography.
|
Double Layer
Age:18-45 Years,Only women who underwent cesarean section 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) Uterus will be sutured in double layer during cesareanDiagnostic Test: Total myometrium thickness, Residual myometrium thickness, Niche Presence and Measurements in 3D will be evaluated in 6th months by saline infusion sonography.
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
141
|
|
Overall Study
COMPLETED
|
109
|
116
|
|
Overall Study
NOT COMPLETED
|
32
|
25
|
Reasons for withdrawal
| Measure |
Single Layer
Age:18-45 Years,Only women who underwent cesarean section 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) Uterus will be sutured in locked single layer during cesarean Diagnostic Test: Total myometrium thickness, Residual myometrium thickness, Niche Presence and Measurements in 3D will be evaluated in 6th months by saline infusion sonography.
|
Double Layer
Age:18-45 Years,Only women who underwent cesarean section 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) Uterus will be sutured in double layer during cesareanDiagnostic Test: Total myometrium thickness, Residual myometrium thickness, Niche Presence and Measurements in 3D will be evaluated in 6th months by saline infusion sonography.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
23
|
|
Overall Study
Pregnancy
|
4
|
2
|
|
Overall Study
intolerance to examination
|
2
|
0
|
Baseline Characteristics
Single or Double-layer Uterine Closure Techniques
Baseline characteristics by cohort
| Measure |
Single Layer
n=109 Participants
uterus will be sutured by single layer
|
Double Layer
n=116 Participants
uterus will be sutured by double layer
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
109 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Body mass index
|
28.9 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=7 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Gestational age at delivery
|
38 weeks
STANDARD_DEVIATION 2 • n=5 Participants
|
38.1 weeks
STANDARD_DEVIATION 2.1 • n=7 Participants
|
38.1 weeks
STANDARD_DEVIATION 2 • n=5 Participants
|
|
birth weight
|
3191.5 g
STANDARD_DEVIATION 570 • n=5 Participants
|
3261.4 g
STANDARD_DEVIATION 633 • n=7 Participants
|
3227.3 g
STANDARD_DEVIATION 602.8 • n=5 Participants
|
|
Tobacco use
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diabetes mellitus
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Hypertension in pregnancy
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
History of infertility
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Nulliparity
|
103 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Emergent cesarean section
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Contractions before labor
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
≥4 cm cervical dilatation
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Need for additional suture
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Duration of uterine closure
|
3.5 min
n=5 Participants
|
6.15 min
n=7 Participants
|
5.2 min
n=5 Participants
|
|
Operation time
|
25 min
n=5 Participants
|
30 min
n=7 Participants
|
27 min
n=5 Participants
|
|
Duration of labor
|
1 hour
n=5 Participants
|
1 hour
n=7 Participants
|
1 hour
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 to 9 monthsThe presence of niche in incision line visualized by saline infusion sonography
Outcome measures
| Measure |
Single Layer
n=109 Participants
niche presence
|
Double Layer
n=116 Participants
niche presence
|
|---|---|---|
|
Number of Participants With Niche Visualized by Saline Infusion Sonography
number and percentage of niche by saline infusion
|
40 Participants
|
53 Participants
|
|
Number of Participants With Niche Visualized by Saline Infusion Sonography
the presence of niche by tv ultrasound
|
25 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 6-9 monthswith saline infusion sonohysterography
Outcome measures
| Measure |
Single Layer
n=109 Participants
niche presence
|
Double Layer
n=116 Participants
niche presence
|
|---|---|---|
|
Median Depth of Niche
|
1.7 mm
Interval 0.0 to 8.4
|
2.4 mm
Interval 0.0 to 6.3
|
PRIMARY outcome
Timeframe: 6-9 monthsPopulation: of the 225 partipicants included the study
by saline infusion sonohysterography
Outcome measures
| Measure |
Single Layer
n=109 Participants
niche presence
|
Double Layer
n=116 Participants
niche presence
|
|---|---|---|
|
Median Length of Niche
|
3.5 mm
Interval 0.0 to 6.7
|
3.8 mm
Interval 0.0 to 9.3
|
PRIMARY outcome
Timeframe: 6-9 monthsPopulation: of the 225 participants included the study
median width of niche in transverse plane by saline infusion sonohysterograhpy
Outcome measures
| Measure |
Single Layer
n=109 Participants
niche presence
|
Double Layer
n=116 Participants
niche presence
|
|---|---|---|
|
Median Width of Niche in Transverse Plane
|
2.8 mm
Interval 0.0 to 7.4
|
4 mm
Interval 0.0 to 10.1
|
SECONDARY outcome
Timeframe: 6 to 9 monthsThe residual myometrium thickness in incision line measured by saline infusion sonography
Outcome measures
| Measure |
Single Layer
n=109 Participants
niche presence
|
Double Layer
n=116 Participants
niche presence
|
|---|---|---|
|
Residual Myometrium Thickness - 6 to 9 Months
|
9.6 mm
Interval 3.7 to 21.0
|
9.4 mm
Interval 3.0 to 23.0
|
SECONDARY outcome
Timeframe: 6 to 9 monthsAdjacent myometrium thickness out of incision line measured by saline infusion sonography
Outcome measures
| Measure |
Single Layer
n=109 Participants
niche presence
|
Double Layer
n=116 Participants
niche presence
|
|---|---|---|
|
Adjacent Myometrium Thickness
|
12.1 mm
Interval 6.8 to 22.6
|
12 mm
Interval 4.9 to 23.0
|
Adverse Events
Single Layer-
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Double Layer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Layer-
n=109 participants at risk
Presence of niche, niche measurements, measurement of residual/ adjacent myometrium thickness
|
Double Layer
n=116 participants at risk
Presence of niche, niche measurements, measurement of residual/ adjacent myometrium thickness
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
pregnancy occurred after cesarean
|
0.92%
1/109 • Number of events 4 • 6 months
no serious adverse event occured
|
0.00%
0/116 • Number of events 2 • 6 months
no serious adverse event occured
|
Additional Information
Şafak Yılmaz Baran, MD
Principal investigator of the research
Phone: +903224586868
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place