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IRCT20100130003226N18 IRCT 2019-11-11 Shahid Beheshti University of Medical Sciences The effect of Colporea ointment in the treatment of episiotomy wounds. Comparison of the efficacy of Teucrium polium ointment and placebo in the treatment of episiotomy ulcers in primiparous women. 2019-08-21 anticipated 90 Complete https://irct.ir/trial/40004 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Available (simple) and goal-based. In this way, all patients who are eligible for the study will be screened. The delivery of the medicine to the patients is in a box containing a number of cards that are evenly written in the English alphabet "A and B" with the placebo oint code and Teucrium polium(Researcher Unaware of the contents of the worms) we match, and patients choose a card at random. And they deliver the medicine on the letters, Blinding description: This is triple-blind randomized controlled clinical trial. At the diagnostic stage of the demographic and midwifery and delivery questionnaire the patient's name is not written. At the stage of giving the patient a placebo ointment or Teucrium Polium are marked with the English letter A and B, coded by the pharmacist. The researcher is not aware of its contents and the patient also randomly selects one of the placebo ointment or Teucrium Polium. At the referral stage after treatment and the statistics professor is also unaware of the intervention and control groups. 3 Episiotomy. Intervention 1: Intervention group: Uses 2% Colpore ointment for 10 days (daily) at a rate of two centimeters, on episiotomy wound.This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of wound healing is done 24 hours after the intervention and then on the fifth and tenth days. Intervention 2: Control group: Use placebo ointment (quite similar to Calpore ointment) for 2 days (daily) at 2 cm, on episiotomy ulcer. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of wound healing is done 24 hours after the intervention and then on the fifth and tenth days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Mahrokh Dolatian
School of Nursing and Gynecology Department-In front of Shaheed Rajaee Heart Hospital-The intersection of Niayesh-Vali asr street-Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 mhdolatian@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr. Mahrokh Dolatian
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 m_dolatian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Married women aged 18 to 35 years Primiparous Gestational age between 37 to 42 weeks Having a single fetus with cephalic presentation Fetal weight between 2500 and 4000 g BMI between 18.5 and 25 Vaginal delivery with intermediate episiotomy without rupture (grade II) Normal first, second and third stage of the delivery 18 years 35 years Female Amniotic sac rupture more than 24 hours Allergy to Colpore Ointment Having fever, sinus infection and hematoma Infant hospitalization at intensive care unit Having postpartum hemorrhoids or fissures Having sex in the first ten days after delivery obstetric 071.9 Treatment - Drugs Treatment - Drugs Intervention group: Uses 2% Colpore ointment for 10 days (daily) at a rate of two centimeters, on episiotomy wound.This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of wound healing is done 24 hours after the intervention and then on the fifth and tenth days. Control group: Use placebo ointment (quite similar to Calpore ointment) for 2 days (daily) at 2 cm, on episiotomy ulcer. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of wound healing is done 24 hours after the intervention and then on the fifth and tenth days. Episiotomy wound healing. Timepoint: Before the intervention, 24hours, 5 and 10 days after treatment. Method of measurement: REEDA scale assess 5 items such as Redness, Edema, Ecchymoses, Wound secretion, and Wound dehiscence. Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Approved 2019-05-08 Ethics Committee of Shahid Beheshti University of Medical Sciences 6th floor,Building no.2 SBMUS,Parvaneh str.,Yemeni Ave.Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)