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The Effect of Rosa damascene and Phenytoin Cream on pain and episiotomy wound healing

Investigating the Effect of Rosa damascene and Phenytoin Cream on pain and episiotomy wound healing in primiparous women

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220816055724N1
Enrollment
120
Registered
2022-09-02
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Pain. Condition 2: wound healing. Other acute postprocedural pain Disruption of perineal obstetric wound

Interventions

Intervention 1: Intervention group: Rosa damascene cream. cream will be prepared by a traditional medicine pharmacist based on the formulation of Iranian traditional medicine books
In this way, after identifying and ensuring the authenticity of the raw material and some relevant quality factors, the components of the composition are standardized and the samples are controlled fr

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Normal pregnancy and delivery Having at least reading and writing literacy perimiparus Age between 15-45 Body mass index (after delivery) between 18.5-30 kilograms per square meter

Exclusion criteria

Exclusion criteria: Gestational age 37-42 , Cephalic presentation, one alive fetuse suffering from diseases that interfere with wound healing (such as anemia, infection and wounds in the perineum, diabetes, blood pressure, skin, heart, kidney, lung diseases, coagulation disorder, immunodeficiency, hemophilia, disorder connective tissue, depression, malnutrition, mental illnesses, cancer) using drugs effective on wound healing by the mother (anticoagulants, antidepressants, antiepileptics), alcohol, smoking, glucocorticoids, immune system suppressors, antibiotics, and narcotics and psychotropic drugs, not doing The duration of rupture of the Amionitic membran is not more than 18 hours Non-instrumental vaginal delivery with medial and lateral episiotomy incision having a history of previous injury or surgery and visible lesions in the perineum (genital warts, hemorrhoids) and persistent constipation (according to the patient's statement) Spontaneous removal of the placenta

Design outcomes

Primary

MeasureTime frame
Episiotomy wound pain. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy pain on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: Ruler method- Using the VAS questionnaire.;Repair of episiotomy wound. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo onepisiotomy wound healing on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: Reeda questionnaire.

Secondary

MeasureTime frame
Drug side effects. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy Burning on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list.;Redness. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy redness on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list.;Wheal. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy wheal on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Shabani

Arak University of Medical Sciences

fatemeshabani@yahoo.com+98 86 3417 3520

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026