Episiotomy Wound, Labor; Prolonged, Second Stage
Conditions
Keywords
Labor, Vaginal Birth, Episiotomy, Suturing
Brief summary
Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.
Interventions
PROCEDUREMattress Suturing
Horizontal mattress suture in interrupted fashion
PROCEDUREPrimary Suturing
Horizontal primary suture in interrupted fashion
PROCEDUREContinuous Subcutaneous Suturing
Subcutaneous suture in continuous fashion
Sponsors
Başakşehir Çam & Sakura City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Primiparous * Age between 18 to 45 * Given birth in our labor ward
Exclusion criteria
* Multiparous * having deep vaginal lacerations * having abnormalities in fetus * Rheumatologic diseases * Postpartum bleeding * Shoulder Dystocia * Operative Delivery * Using antithrombotic or anticoagulant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score | in postpartum day 15 | 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 |
| Pain by Visual Analog Scale (VAS) | in postpartum day 15 | Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS) |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| 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 | 43 |
| 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 | 43 |
| Total | 129 |
Baseline characteristics
| Characteristic | Total | SC-Suture | I-Suture | M-Suture |
|---|---|---|---|---|
| Active Birth Phase Duration (hours) | 4.7 hours STANDARD_DEVIATION 3.55 | 5.02 hours STANDARD_DEVIATION 3.55 | 4.56 hours STANDARD_DEVIATION 3.22 | 4.52 hours STANDARD_DEVIATION 3.89 |
| Age, Continuous | 23.9 years STANDARD_DEVIATION 3.9 | 24.1 years STANDARD_DEVIATION 4.1 | 24.9 years STANDARD_DEVIATION 4.8 | 22.6 years STANDARD_DEVIATION 2.9 |
| Body Mass Index | 28 kg/m2 STANDARD_DEVIATION 4.2 | 28.3 kg/m2 STANDARD_DEVIATION 5 | 27.3 kg/m2 STANDARD_DEVIATION 3.1 | 28.4 kg/m2 STANDARD_DEVIATION 4.5 |
| Gestational Age at Delivery | 38.97 weeks STANDARD_DEVIATION 1.66 | 39.21 weeks STANDARD_DEVIATION 1.33 | 38.56 weeks STANDARD_DEVIATION 2.14 | 39.15 weeks STANDARD_DEVIATION 1.5 |
| Labor Induction | 82 Participants | 26 Participants | 26 Participants | 30 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment Turkey | 129 Participants | 43 Participants | 43 Participants | 43 Participants |
| Sex: Female, Male Female | 129 Participants | 43 Participants | 43 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoker | 11 Participants | 6 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 4 / 43 | 2 / 43 | 3 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 | 0 / 43 |
Outcome results
Primary
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
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
Time frame: in postpartum day 15
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M-Suture | Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score | 1 REEDA Score |
| I-Suture | Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score | 1 REEDA Score |
| SC-Suture | Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score | 0 REEDA Score |
Primary
Pain by Visual Analog Scale (VAS)
Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS)
Time frame: in postpartum day 15
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M-Suture | Pain by Visual Analog Scale (VAS) | 2 VAS Score |
| I-Suture | Pain by Visual Analog Scale (VAS) | 2 VAS Score |
| SC-Suture | Pain by Visual Analog Scale (VAS) | 1 VAS Score |