Single or Double-layer Uterine Closure Techniques
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Study design and participants This study will be assessed cesarean delivery (CD) patients who will admit to the Obstetrics and Gynecology Clinic of the Başkent University Adana Dr. Turgut Noyan Research and Application Center between July 2018 and September 2019. Specifically, participants will be singleton pregnancy patients between 18-45 years of age who will be in gestational weeks 24-41 and had not previously received any uterine operations such as CS or myomectomy. Patients with multiple pregnancies and/or chronic inflammatory diseases such as systemic lupus erythematosus, rheumatoid arthritis, and insulin-dependent diabetes mellitus will be excluded. All patients who meet the inclusion criteria will be randomized into two treatment groups (i.e., single- or double-layer closures).
This study was approved by Başkent University Institutional Review Board and Ethics Committee (Project no= KA18-71, Approval Date= 7/27/2018), and supported by Başkent University Research Fund. Patients who will agree to participate in the study will be informed about the purpose of the study before their operations, and each provided signed written consent.
Participants will be also assessed for maternal age, gravidity, parity, body mass index, smoking status, diabetes mellitus, hypertensive diseases of pregnancy, and medical history. Regardless of whether they had contractions before surgery, this study also will be determined patient CD indications, levels of cervical dilatation, and how CD will be established (i.e., elective or emergent).
Randomization and masking A table of random numbers is used as a simple randomization method for placing participants into the two treatment groups. The Research Randomizer website (https://www.randomizer.org/) was used to create this table. Before the intervention, the next envelope among a previously prepared, sealed, and the number-ordered stack will be opened by a nurse for each procedure.
Surgery technique Six operators will perform CD operations. Access to the abdomen will be achieved via Pfannenstiel incision, while the Kerr incision technique will be applied to the uterus for all patients. Patients in the single-layer group will be received uterus closures with locking, while patients in the double-layer group will be received uterus closures with locking in the first layer, but without locking and using the Lambert style in the second layer. The decidua will be deliberately excluded during all suturations. A synthetic absorbable suture material (Vicryl 1.0, Ethicon, Somerville, NJ, USA) will be used during all uterus closures, with corner stitches that will be applied to all patients. Additional suture usages and numbers will be reported only in cases of bleeding. Both uterine closure and whole operation times will be recorded by the respective operating room technicians. Finally, intravenous prophylactic antibiotics (2 g cefazolin sodium) and uterotonic medications (10 IU oxytocin) will be routinely applied during all CD procedures.
Follow-up Postoperative follow-ups will be completed in March 2020. All participants will be called after delivery and will be invited to complete sixth-month evaluations. However, participants who will experience post-CD pregnancies or uterine surgeries will be excluded. All remaining participants will be examined at six to nine months period after CD for niche presence in the scar region, niche measurements, scar shape, distance between niche and the external cervical os and residual myometrium thickness (RMT), and adjacent myometrium thicknesses (AMT). The distance between the niche and external os should be measured parallel to the top of the main niche, from the most distal niche point to external os. These examinations will be conducted by two experienced sonographers who will be blinded to clinical information regarding the closure technique. Procedures will be specifically completed using a 4-10 MHz transducer (E8C-RS micro convex endocavity probe, Voluson S6, GE, Milwaukee, US), ultrasonography, and through the saline infusion sonohysterography (SIS) method. The cervix will be first cleaned with povidone iodine while the patient will be on the gynecological examination table prior to ultrasonography. The SIS process then will be progressed toward the inside of the endometrial cavity by passing from the cervical os with an intrauterine insemination cannula (intrauterine insemination catheter, Wallace Artificial Insemination Catheter, Smiths Medical International Ltd., Ashford, Kent, UK). A sterile saline solution will be applied to sufficiently distend the cavity, while ultrasonography will be conducted via transvaginal probe. At this time, the presence of a hypoechogenic area with a depth of 2mm or deeper in the CD scar region within the endometrial cavity will be accepted as a niche. Niche dimensions will be determined via 3-axis measurements for depth, length, and width. Niche shape, distance to the external cervical os, RMT, and AMT will be evaluated. During these follow-ups, patients will be also asked about their menstruation processes and any experiences of cervical pain, menstruation pain, postmenstrual bleeding (PMB) in the form of spotting, and other abnormal bleeding patterns. Those who will experience bleeding for two days or more in the form of spotting after menstruation will be defined as PMB. Participants who will use intrauterine devices after CD and/or those who could not tolerate speculum application will be examined via transvaginal ultrasonography (TV USG).
Outcomes Primary outcomes will be considered niche presence and measurements, while secondary outcomes will be considered RMT, AMT, healing ratio, postmenstrual spotting, and dysmenorrhea.
Statistical analyses The sample size was calculated based on a study by Di Spiezio Sardo et al. (2017) titled Risk of Cesarean Scar Defect Following Single- vs Double-Layer Uterine Closure: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Their study revealed niche formation rates for single- and double-layer closure types of 25% and 43%, respectively. Based on tools available at the Power and Sample Size website (http://powerandsamplesize.com/Calculators), the needed sample size was calculated at 141 for each treatment group with 90% power and 0.05 alpha error.
All data were statistically analyzed using the IBM SPSS 21.0 software. Categorical measurements will be presented as frequencies and percentages, while continuous measurements will be summarized as means and standard deviations (median and range when needed). Distributions will be checked and the student's t-test was will be used for variables meeting the parametric test assumptions when comparing the continuous measurements based on groups, while the Mann Whitney U test will be used for those that will not meet the parametric test assumptions. Finally, chi-square or Fisher's test statistics will be used to compare categorical variables. Statistical significance is set to 0.05 for all tests.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Single Layer Diagnostic Test: Niche Presence in 6 to 9 months Diagnostic Test: Niche Measurements (depth of niche, the length of niche, the width of the niche in the transverse plane) Diagnostic Test: Residual myometrium thickness Diagnostic Test: Adjacent myometrium thickness Symptoms: postmenstrual bleeding/dysmenorrhea |
Diagnostic Test: Residual myometrium thickness
The myometrium will be closed by single or double layer during cesarean and residual myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.
Diagnostic Test: Niche Presence
The myometrium will be closed by single or double layer during cesarean and niche presence will be evaluated in 6 to 9 months by saline infusion sonography.
Diagnostic Test: Adjacent myometrium thickness
The myometrium will be closed by single or double layer during cesarean and adjacent myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.
Diagnostic Test: Niche Measurements (depth of niche, width of niche, length of niche)
The myometrium will be closed by single or double layer during cesarean and three dimensional niche measurements will be evaluated in 6 to 9 months by saline infusion sonography.
|
| Active Comparator: Double Layer Diagnostic Test: Niche Presence in 6 to 9 months Diagnostic Test: Niche Measurements (depth of niche, the length of niche, the width of the niche in the transverse plane) Diagnostic Test: Residual myometrium thickness Diagnostic Test: Adjacent myometrium thickness Symptoms: postmenstrual bleeding/dysmenorrhea |
Diagnostic Test: Residual myometrium thickness
The myometrium will be closed by single or double layer during cesarean and residual myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.
Diagnostic Test: Niche Presence
The myometrium will be closed by single or double layer during cesarean and niche presence will be evaluated in 6 to 9 months by saline infusion sonography.
Diagnostic Test: Adjacent myometrium thickness
The myometrium will be closed by single or double layer during cesarean and adjacent myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.
Diagnostic Test: Niche Measurements (depth of niche, width of niche, length of niche)
The myometrium will be closed by single or double layer during cesarean and three dimensional niche measurements will be evaluated in 6 to 9 months by saline infusion sonography.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Niche Visualized by Saline Infusion Sonography [6 to 9 months]
The presence of niche in incision line visualized by saline infusion sonography
- Median Depth of Niche [6-9 months]
with saline infusion sonohysterography
- Median Length of Niche [6-9 months]
by saline infusion sonohysterography
- Median Width of Niche in Transverse Plane [6-9 months]
median width of niche in transverse plane by saline infusion sonohysterograhpy
Secondary Outcome Measures
- Residual Myometrium Thickness - 6 to 9 Months [6 to 9 months]
The residual myometrium thickness in incision line measured by saline infusion sonography
- Adjacent Myometrium Thickness [6 to 9 months]
Adjacent myometrium thickness out of incision line measured by saline infusion sonography
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baskent University Adana Seyhan Uygulama Hastanesi | Adana | Turkey |
Sponsors and Collaborators
- Safak Baran Yilmaz
Investigators
- Principal Investigator: Şafak YILMAZ BARAN, M.D., Baskent University Department of Obstetrics and Gynecology
Study Documents (Full-Text)
More Information
Publications
- KA 18/71
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Layer | Double Layer |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 141 | 141 |
| COMPLETED | 109 | 116 |
| NOT COMPLETED | 32 | 25 |
Baseline Characteristics
| Arm/Group Title | Single Layer | Double Layer | Total |
|---|---|---|---|
| Arm/Group Description | uterus will be sutured by single layer | uterus will be sutured by double layer | Total of all reporting groups |
| Overall Participants | 109 | 116 | 225 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
29.8
(4.1)
|
30.8
(5.1)
|
30.3
(4.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
109
100%
|
116
100%
|
225
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
109
100%
|
116
100%
|
225
100%
|
| Body mass index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
28.9
(4.2)
|
29.8
(4.6)
|
29.3
(4.4)
|
| Gestational age at delivery (weeks) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [weeks] |
38
(2)
|
38.1
(2.1)
|
38.1
(2)
|
| birth weight (g) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g] |
3191.5
(570)
|
3261.4
(633)
|
3227.3
(602.8)
|
| Tobacco use (Count of Participants) | |||
| Count of Participants [Participants] |
5
4.6%
|
4
3.4%
|
9
4%
|
| Diabetes mellitus (Count of Participants) | |||
| Count of Participants [Participants] |
6
5.5%
|
9
7.8%
|
15
6.7%
|
| Hypertension in pregnancy (Count of Participants) | |||
| Count of Participants [Participants] |
10
9.2%
|
9
7.8%
|
19
8.4%
|
| History of infertility (Count of Participants) | |||
| Count of Participants [Participants] |
22
20.2%
|
25
21.6%
|
47
20.9%
|
| Nulliparity (Count of Participants) | |||
| Count of Participants [Participants] |
103
94.5%
|
105
90.5%
|
208
92.4%
|
| Emergent cesarean section (Count of Participants) | |||
| Count of Participants [Participants] |
30
27.5%
|
35
30.2%
|
65
28.9%
|
| Contractions before labor (Count of Participants) | |||
| Count of Participants [Participants] |
29
26.6%
|
34
29.3%
|
63
28%
|
| ≥4 cm cervical dilatation (Count of Participants) | |||
| Count of Participants [Participants] |
11
10.1%
|
14
12.1%
|
25
11.1%
|
| Need for additional suture (Count of Participants) | |||
| Count of Participants [Participants] |
64
58.7%
|
66
56.9%
|
130
57.8%
|
| Duration of uterine closure (min) [Median (Full Range) ] | |||
| Median (Full Range) [min] |
3.5
|
6.15
|
5.2
|
| Operation time (min) [Median (Full Range) ] | |||
| Median (Full Range) [min] |
25
|
30
|
27
|
| Duration of labor (hour) [Median (Full Range) ] | |||
| Median (Full Range) [hour] |
1
|
1
|
1
|
Outcome Measures
| Title | Number of Participants With Niche Visualized by Saline Infusion Sonography |
|---|---|
| Description | The presence of niche in incision line visualized by saline infusion sonography |
| Time Frame | 6 to 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Layer | Double Layer |
|---|---|---|
| Arm/Group Description | niche presence | niche presence |
| Measure Participants | 109 | 116 |
| number and percentage of niche by saline infusion |
40
36.7%
|
53
45.7%
|
| the presence of niche by tv ultrasound |
25
22.9%
|
23
19.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Single Layer, Double Layer |
|---|---|---|
| Comments | The sample size was calculated based on the study of Sardo et al. The website http://powerandsamplesize.com/Calculators was used. As a result of the sample size calculation with 90% power and 0.05 alpha error, it was planned to include 141 patients in each group. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | Data compared to meta-analysis conducted in Sardo et al., 2017 | |
| Statistical Test of Hypothesis | p-Value | 0.05 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Chi-squared or Fisher's test statistic was used to compare the categorical variables. | |
| Title | Median Depth of Niche |
|---|---|
| Description | with saline infusion sonohysterography |
| Time Frame | 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Layer | Double Layer |
|---|---|---|
| Arm/Group Description | single layer median depth of niche | double layer median depth of niche |
| Measure Participants | 109 | 116 |
| Median (Full Range) [mm] |
1.7
|
2.4
|
| Title | Median Length of Niche |
|---|---|
| Description | by saline infusion sonohysterography |
| Time Frame | 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| of the 225 partipicants included the study |
| Arm/Group Title | Single Layer | Double Layer |
|---|---|---|
| Arm/Group Description | median length niche | median length niche |
| Measure Participants | 109 | 116 |
| Median (Full Range) [mm] |
3.5
|
3.8
|
| Title | Median Width of Niche in Transverse Plane |
|---|---|
| Description | median width of niche in transverse plane by saline infusion sonohysterograhpy |
| Time Frame | 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| of the 225 participants included the study |
| Arm/Group Title | Single Layer | Double Layer |
|---|---|---|
| Arm/Group Description | median niche width in transverse plane | median niche width in transverse plane |
| Measure Participants | 109 | 116 |
| Median (Full Range) [mm] |
2.8
|
4
|
| Title | Residual Myometrium Thickness - 6 to 9 Months |
|---|---|
| Description | The residual myometrium thickness in incision line measured by saline infusion sonography |
| Time Frame | 6 to 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Layer | Double Layer |
|---|---|---|
| Arm/Group Description | Residual myometrium thickness | Residual myometrium thickness |
| Measure Participants | 109 | 116 |
| Median (Full Range) [mm] |
9.6
|
9.4
|
| Title | Adjacent Myometrium Thickness |
|---|---|
| Description | Adjacent myometrium thickness out of incision line measured by saline infusion sonography |
| Time Frame | 6 to 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Layer | Double Layer |
|---|---|---|
| Arm/Group Description | Adjacent myometrium thickness | adjacent myometrium thickness |
| Measure Participants | 109 | 116 |
| Median (Full Range) [mm] |
12.1
|
12
|
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | no serious adverse event occured | |||
| Arm/Group Title | Single Layer- | Double Layer | ||
| Arm/Group Description | Presence of niche, niche measurements, measurement of residual/ adjacent myometrium thickness | Presence of niche, niche measurements, measurement of residual/ adjacent myometrium thickness | ||
All Cause Mortality |
||||
| Single Layer- | Double Layer | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/109 (0%) | 0/116 (0%) | ||
Serious Adverse Events |
||||
| Single Layer- | Double Layer | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/109 (0%) | 0/116 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Single Layer- | Double Layer | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/109 (0.9%) | 0/116 (0%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| pregnancy occurred after cesarean | 1/109 (0.9%) | 4 | 1/116 (0.9%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Şafak Yılmaz Baran, MD |
|---|---|
| Organization | Principal investigator of the research |
| Phone | +903224586868 |
| safakyilmazbaran@gmail.com |
- KA 18/71