The effect of combination of Chamomile and Calendula oficinalis on Episiotomy wound healing and pain in nulliparous wome

Phase 2

Completed

• Conditions: wound healing of episiotomy , pain of episiotomy.; Disruption of perineal obstetric wound

• Registration Number: IRCT2015102624712N1
• Lead Sponsor: Vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Scienc

Brief Summary

Investigating the Effect of Chamomile-Marigold Combination Ointment on Episiotomy Wound Recovery in Nulliparous Women <br /> Abstract<br /> Aim: Episiotomy, which was first presented in 1920, is one of the most common obstetrics interventions proposed as a way to prevent injuries to pelvic floor and the head of the fetus during labor. Marigold, with the scientific name of Calendula Officinalis, has pharmacological and therapeutic effects, such as wound healing, anti-inflammatory, antibacterial, immune stimulation, anti-tumor, anti-AIDS, and etc. chamomile is also one of those plants which are anti-inflammatory, antibacterial, and antioxidant. Therefore, the present study was done to investigate the effect of chamomile-marigold combination ointment on episiotomy wound recovery in nulliparous women.<br /> Methods:The present randomized clinical study was conducted on 99 women who met the inclusion criteria in Shahid Akbar Abadi hospital from January 2015 to June 2016. The samples were divided in three groups of chamomile-marigold combination ointment, placebo, and control using random number table. Then, samples were collected 4 hours after labor and episiotomy wounds were started to get cured using 20mg of prescribed ointment, the equivalent of a knuckle, for 8 hours during 10 days. REEDA instrument was used to measure the degree of episiotomy sound recovery 1, 5, and 10 days after labor. Data analysis was performed through SPSS statistical software, Version 20, Fisher exact tests, analysis of variance, Chi-square, and non-parametric tests of Kruskal-Wallis, median, and Friedman. Less than 0.05 P value was considered significant.<br /> Findings:Based on variance analysis, three under study groups did not have statistically significant difference in terms of sound healing prior to intervention (p=0.964); however, comparison of wound healing scores 1, 5, and 10 days after intervention showed statistically significant difference among three groups. (P< 0.001)<br /> Conclusion:Due to healing, anti-inflammatory, and antibacterial properties, chamomile-marigold combination ointment increases episiotomy wound recovery significantly and it can be recommended for nulliparous women which are afflicted with mentioned injury.<br /> Keyword: Episiotomy, Chamomile, Marigold, Wound Recovery <br />

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

being primiparous women with age range 18-35 years; gestational age 37-42 weeks; single pregnancy; cephalic presentation;ability to read and write; living with his wife's; insensitivity to special herbal drugs in past; non-smoking and no drug dependence; no history of disease impaired wound healing; Lack PROM more than 18 hours; absence of reconstructive surgery on the vagina and perineum; No rectocel, cystocele severe (grade 2 or higher), wall or mass in the vagina; mediolateral episiotomy without rupture and spread with same amount of Lidocaine; lack of volvo and vaginal inflammation at the beginning of research; body mass index less than 30;. Exclusion criteria: there interfere with the progress of labor; prolonged second stage of labor longer than 2 hours; extend the length of the incision or there tear except episiotomy tear; abnormal vaginal bleeding; shoulder dystocia (leading to the maneuvers other than Robert Mack); manual removal of placenta; hematoma; having intercourse to the end of the study (10 days postpartum); curettage procedure the first 24 hours after birth; not use the ointment on a regular; puerperal fever; an infection of episiotomy; need to re-stitch the episiotomy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episiotomy wound healing. Timepoint: 4 hours after delivery, 1 days after delivery, 5 days after delivery ,and 10 days after delivery. Method of measurement: REEDA Scale of wound healing.;Pain in episiotomy. Timepoint: 4 hours after delivery, 1 days after delivery, 5 days after delivery ,and 10 days after delivery. Method of measurement: Visual analog scale.

Secondary Outcome Measures

Name	Time	Method
Sedative tablets counting. Timepoint: Tenth day after delivery. Method of measurement: questionnaire.