Trial Outcomes & Findings for The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain (NCT NCT06379048)
NCT ID: NCT06379048
Last Updated: 2025-06-12
Results Overview
Healing is assessed by Redness, Edema, Ecchymosis and Discharge (REEDA) Score REEDA Scale: Healed: 0; moderately healed: 1 to 5; mildly healed: 6 to 10; and not healed: 11 to 15
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
in postpartum day 15
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
M-Suture
Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm.
Mattress Suturing: Horizontal mattress suture in interrupted fashion
|
I-Suture
Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.
Primary Suturing: Horizontal primary suture in interrupted fashion
|
SC-Suture
Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm.
Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
44
|
|
Overall Study
COMPLETED
|
43
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
M-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm.
Mattress Suturing: Horizontal mattress suture in interrupted fashion
|
I-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.
Primary Suturing: Horizontal primary suture in interrupted fashion
|
SC-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm.
Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.6 years
STANDARD_DEVIATION 2.9 • n=43 Participants
|
24.9 years
STANDARD_DEVIATION 4.8 • n=43 Participants
|
24.1 years
STANDARD_DEVIATION 4.1 • n=43 Participants
|
23.9 years
STANDARD_DEVIATION 3.9 • n=129 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=43 Participants
|
43 Participants
n=43 Participants
|
43 Participants
n=43 Participants
|
129 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=129 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
43 Participants
n=43 Participants
|
43 Participants
n=43 Participants
|
43 Participants
n=43 Participants
|
129 Participants
n=129 Participants
|
|
Smoker
|
2 Participants
n=43 Participants
|
3 Participants
n=43 Participants
|
6 Participants
n=43 Participants
|
11 Participants
n=129 Participants
|
|
Body Mass Index
|
28.4 kg/m2
STANDARD_DEVIATION 4.5 • n=43 Participants
|
27.3 kg/m2
STANDARD_DEVIATION 3.1 • n=43 Participants
|
28.3 kg/m2
STANDARD_DEVIATION 5 • n=43 Participants
|
28 kg/m2
STANDARD_DEVIATION 4.2 • n=129 Participants
|
|
Gestational Age at Delivery
|
39.15 weeks
STANDARD_DEVIATION 1.5 • n=43 Participants
|
38.56 weeks
STANDARD_DEVIATION 2.14 • n=43 Participants
|
39.21 weeks
STANDARD_DEVIATION 1.33 • n=43 Participants
|
38.97 weeks
STANDARD_DEVIATION 1.66 • n=129 Participants
|
|
Labor Induction
|
30 Participants
n=43 Participants
|
26 Participants
n=43 Participants
|
26 Participants
n=43 Participants
|
82 Participants
n=129 Participants
|
|
Active Birth Phase Duration (hours)
|
4.52 hours
STANDARD_DEVIATION 3.89 • n=43 Participants
|
4.56 hours
STANDARD_DEVIATION 3.22 • n=43 Participants
|
5.02 hours
STANDARD_DEVIATION 3.55 • n=43 Participants
|
4.7 hours
STANDARD_DEVIATION 3.55 • n=129 Participants
|
PRIMARY outcome
Timeframe: in postpartum day 15Healing is assessed by Redness, Edema, Ecchymosis and Discharge (REEDA) Score REEDA Scale: Healed: 0; moderately healed: 1 to 5; mildly healed: 6 to 10; and not healed: 11 to 15
Outcome measures
| Measure |
M-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm.
Mattress Suturing: Horizontal mattress suture in interrupted fashion
|
I-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.
Primary Suturing: Horizontal primary suture in interrupted fashion
|
SC-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm.
Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion
|
|---|---|---|---|
|
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
|
1 REEDA Score
Interval 0.0 to 10.0
|
1 REEDA Score
Interval 0.0 to 9.0
|
0 REEDA Score
Interval 0.0 to 5.0
|
PRIMARY outcome
Timeframe: in postpartum day 15Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS)
Outcome measures
| Measure |
M-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm.
Mattress Suturing: Horizontal mattress suture in interrupted fashion
|
I-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.
Primary Suturing: Horizontal primary suture in interrupted fashion
|
SC-Suture
n=43 Participants
Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm.
Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion
|
|---|---|---|---|
|
Pain by Visual Analog Scale (VAS)
|
2 VAS Score
Interval 0.0 to 10.0
|
2 VAS Score
Interval 0.0 to 10.0
|
1 VAS Score
Interval 0.0 to 8.0
|
Adverse Events
M-Suture
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
I-Suture
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SC-Suture
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
M-Suture
n=43 participants at risk
Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm.
Mattress Suturing: Horizontal mattress suture in interrupted fashion
|
I-Suture
n=43 participants at risk
Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.
Primary Suturing: Horizontal primary suture in interrupted fashion
|
SC-Suture
n=43 participants at risk
Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm.
Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Dehiscense
|
2.3%
1/43 • Number of events 1 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
2.3%
1/43 • Number of events 1 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
0.00%
0/43 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
|
Pregnancy, puerperium and perinatal conditions
Urinary Incontinence
|
4.7%
2/43 • Number of events 2 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
2.3%
1/43 • Number of events 1 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
4.7%
2/43 • Number of events 2 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
|
Pregnancy, puerperium and perinatal conditions
Fecal Incontinence
|
4.7%
2/43 • Number of events 2 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
0.00%
0/43 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
2.3%
1/43 • Number of events 1 • 15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place