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IRCT20220314054275N1 IRCT 2022-06-23 Mashhad University of Medical Sciences The effect of sumac capsule on postpartum hemorrhage in women at risk of bleeding The effect of sumac capsule on postpartum hemorrhage in women at risk of bleeding 2022-06-20 anticipated 72 Complete https://irct.ir/trial/62487 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure an equal number of subjects in the two groups, the permutation block method will be used. For this purpose, we will use the website www.sealedenvelope.com in such a way that a number of 6 and 4 member blocks are accidentally created through the above site. Examples of blocks can be: [ABAB], [ABBAAB], [BBAABA], [BAAABB],…Sumac and placebo capsules are coded by the assistant professor of pharmacology and the researcher is unaware of which drug and which placebo. At the end of the analysis, the researcher and professor of statistics, will be revealed that which group has been drugs and placebo, Blinding description: Sumac and placebo capsules are coded by the assistant professor of pharmacology and the researcher is unaware of which drug and which placebo. At the end of the analysis, the researcher and professor of statistics will be revealed that which group has been drugs or placebo. 3 Postpartum haemorrhage. Intervention 1: Intervention group: In addition to routine method of oxytocin , intervention group will be given two oral capsules of 500 mg of dry sumac extract with a yield of 30% (equivalent to 1 gram of sumac) immediately after placental abruption and 2 hours later. Intervention 2: Control group: In addition to the routine method of oxytocin , will be given placebo (500 mg capsule containing an inert substance (Avisel powder) immediately after placental abruption and 2 hours later. Yes - There is a plan to make this available What will be shared: Publication of research results in the form of scientific article printing When: data will become available after publication of the article. To whom: The general public and all researchers Conditions: To inform the public about the reduction of postpartum hemorrhage rate in women at risk of bleeding and scientific use based on the article. Where to obtain: Dr. Maryam Moradi, Assistant Professor, Mashhad School of Midwifery Nursing, e-mail: moradim@mums.ac.ir How to obtain: Request to access data/documents would be assessed by the research team. Comments:
public Mahsa Payranj
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
Mashhad Iran (Islamic Republic of) 9137913199 0098 51 38591511-3 payranjm982@mums.ac.ir Mashhad University of Medical Sciences scientific Maryam Moradi
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
Mashhad Iran (Islamic Republic of) 9137913199 0098 51 3-38591511-3 moradim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Written consent to participate in the study Iranian and resident of Torbat Heydariyeh Literacy age range between 15-50 Tendency to have a normal delivery Term pregnancy Beginning of the active phase of labor Achieve a score equal to or greater than 10% of the prognosis of postpartum hemorrhage No major medical illness No history of cesarean section or uterine surgery lack of take Special drugs lack of Grade 3 and 4 rupture lack of severe bleeding during childbirth lack of herbal or chemical drugs before childbirth and during labor and delivery lack of rupture of cervix and uterus lack of labor complications in the active phase of labor lack of Temperatures greater than 38 ° C during the study lack of rupture of fetal membranes for more than 12 hours Lack of fast labor Lack of prolonged labor No history of allergy to sumac, according to the mother's report lack of Cesarean delivery 15 years 50 years Female Serious postpartum complications in the mother The mother's unwillingness to continue participating in the study Occurrence of any allergy to sumac Leakage of urine during blood collection Need for invasive actions and medication to control severe postpartum hemorrhage (sample will be recorded and excluded) JA43.0 A condition characterised by excessive loss of blood during the third stage of labour for a vaginal delivery. This condition is caused by uterine atony, trauma, retained placenta, or coagulopathy Treatment - Drugs Treatment - Drugs Intervention group: In addition to routine method of oxytocin , intervention group will be given two oral capsules of 500 mg of dry sumac extract with a yield of 30% (equivalent to 1 gram of sumac) immediately after placental abruption and 2 hours later. Control group: In addition to the routine method of oxytocin , will be given placebo (500 mg capsule containing an inert substance (Avisel powder) immediately after placental abruption and 2 hours later. The amount of postpartum hemorrhage. Timepoint: at the end of 1, 2, 3 and 4 hours after delivery. Method of measurement: Weighing blood collection bags and blood-soaked pads. Mashhad University of Medical Sciences Approved 2022-03-15 Ethics Committee of Mashhad University of Medical Sciences Qureshi Building University Street, Mashhad, Iran mashhad Razavi Khorasan Iran (Islamic Republic of)