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IRCT20210121050098N1 IRCT 2021-03-24 Mashhad University of Medical Sciences The effect of topical use of breast milk on episiotomy healing in Primiparous women at high risk for wound infection The effect of topical use of breast milk on episiotomy healing in Primiparous women at high risk for wound infection 2021-02-19 anticipated 72 Complete https://irct.ir/trial/53943 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling is available by simple random assignment. After determining the sample size, through a table of random numbers using the site www.randomization.com, the numbers are divided into two groups of sequences marked with the letters A and B. The sequence stored in sealed envelopes that the researcher uses when selecting a research unit to send individuals to two groups that meet the inclusion criteria. N/A episiotomy wound healing. Intervention 1: Intervention group: In addition to routine rinsing of the perineal episiotomy with normal saline 9% non-injectable (twice a day every 12 hours - routine washing of Mashhad training hospitals with normal saline for ten days), the perineal wound will be soaked in breast milk. This is done for ten days after delivery twice a day (every 12 hours) each time with a new 5 ml syringe at the rate of 2 ml of breast milk and with a 2 ml syringe without a needle from the first day on the perineal wound. It is instilled (in the first three days, this amount is 0.25 ml, which is instilled into the perineal wound) and then gently squeezed with gas for 3 minutes. Intervention 2: Control group: Recommended to wash the perineum with 9% non-injectable normal saline twice a day for ten days (according to the routine of Umm Al-Banin Hospital in Mashhad). Yes - There is a plan to make this available What will be shared: Documents are shared after being unidentified When: 8 months To whom: All researchers Conditions: All women with natural childbirth who have had an episiotomy and Midwifery service personnel Where to obtain: To email address hoseinik973@mums.ac.ir How to obtain: First, send an e-mail and if you do not respond within a week, you can refer to the library of Mashhad School of Nursing and Midwifery at Ibn Sina St. Comments:
public Kobra Sadat Hosseini
School of Nursing and Midwifery, Ibn Sina St., Doctora Intersection, Daneshgah St., Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 hoseinik973@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Jahani Shorab
School of Nursing and Midwifery, Ibn Sina St., Doctora Intersection, Daneshgah St., Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 jahanishn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iranian nationality and resident of Mashhad Have at least literacy Have informed consent to participate in the research The gestational age is between 38 - 42 weeks The fetus is single and alive Show the fetus at the top of the head Vaginal and spontaneous delivery has been performed Be primiparous Episiotomy incision should be of the mediultral type Have at least two conditions predisposing to infection at the same time The episiotomy is first and second degree 15 years 49 years Female Do follow a special diet . such as a diet of vegetables or just meat Do use tobacco or drugs The fetus does suffer from severe and persistent respiratory distress Do use certain medications (including anticoagulants, antidepressants, antiepileptics, alcohol and benzodiazepines) Use of assistive devices in natural childbirth The death of a baby or infant with major abnormalities Have a history of reconstructive surgery and vaginal and perineum lesions O86.0 Infection of obstetric surgical wound Treatment - Other Treatment - Other Intervention group: In addition to routine rinsing of the perineal episiotomy with normal saline 9% non-injectable (twice a day every 12 hours - routine washing of Mashhad training hospitals with normal saline for ten days), the perineal wound will be soaked in breast milk. This is done for ten days after delivery twice a day (every 12 hours) each time with a new 5 ml syringe at the rate of 2 ml of breast milk and with a 2 ml syringe without a needle from the first day on the perineal wound. It is instilled (in the first three days, this amount is 0.25 ml, which is instilled into the perineal wound) and then gently squeezed with gas for 3 minutes. Control group: Recommended to wash the perineum with 9% non-injectable normal saline twice a day for ten days (according to the routine of Umm Al-Banin Hospital in Mashhad) Redness. Timepoint: The first 24 hours, the fifth and tenth days after delivery. Method of measurement: REEDA Scale. Edema. Timepoint: The first 24 hours, the fifth and tenth days after delivery. Method of measurement: REEDA Scale. Ecchymosis. Timepoint: The first 24 hours, the fifth and tenth days after delivery. Method of measurement: REEDA Scale. Discharge. Timepoint: The first 24 hours, the fifth and tenth days after delivery. Method of measurement: REEDA Scale. Approximation. Timepoint: The first 24 hours, the fifth and tenth days after delivery. Method of measurement: REEDA Scale. The rate of episiotomy healing in women at high risk for wound infection. Timepoint: The first 24 hours, days five and ten after delivery. Method of measurement: REEDA Scale. Mashhad University of Medical Sciences Approved 2020-12-29 Ethics Committee of Mashhad University of Medical Sciences, School of Nursing and Midwifery School of Nursing and Midwifery, Doktora Crossroads, Daneshgah St., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)