Evaluation the effect of Malva sylvestris L extract ointment on pain intensity and incision of during delivery wound healing in primiparous wome
Phase 3
Recruiting
- Conditions
- Episiotomy.Perineal laceration during delivery
- Registration Number
- IRCT20100130003226N19
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 112
Inclusion Criteria
Married women aged 18 to 35 years primiparous
Being Iranian
Gestational age between 37 to 42 weeks
No smoking, alcohol and drugs
Being literate in reading and writing
Having a single fetus with cephalic presentation
Fetal weight between 2500 and 4000 gr
Body Mass Index (BMI) between 18.5 and 25
Vaginal delivery with mediolateral episiotomy
The normality of the first, second and third stages of labor
Exclusion Criteria
Amniotic sac rupture more than 24 hours
Allergy to Malva sylvestris L ointment
Having fever, puerperal infection and hematoma
Infant hospitalization at Neonatal Intensive Care Unit
Having postpartum hemorrhoids or fissures
Having sex in the first ten days after delivery
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Episiotomy wound healing. Timepoint: Before the intervention, the first 24 hours, 5 and 10 days after treatment. Method of measurement: REEDA scale assess 5 items such as Redness, Edema, Ecchymoses, Discharge from the wound and Approximation of the perineal tissues.;Episiotomy wound pain intensity. Timepoint: Before the intervention, the first 24 hours, 5 and 10 days after treatment. Method of measurement: The visual pain scale (VAS) is a tool for measuring the intensity of pain, which is a 10 cm ruler with eleven numbers.
- Secondary Outcome Measures
Name Time Method