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IRCT20181007041266N1 IRCT 2018-12-28 Mashhad University of Medical Sciences Investigation effect of purslane seed on postpartum hemorrhage and after pain Investigation effect of purslane seed capsul on postpartum hemorrhage and after pain in multiparous mothers 2018-11-22 anticipated 70 Complete https://irct.ir/trial/35047 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of mothers is done by simple randomization with random numbers table in sealed envelope. That's 70 pack contains 35 packages containing four capsules of the placebo (code B) and 35 packages containing four purslane seed capsules (code A).The even numbers for the intervention group (code A) and the odd numbers for the control group (code B ) Is considered.Encoding of capsules is done by the pharmacist,The capsules look quite similar, and the researcher and the mothers are unaware of the code of the groups.Participants will randomly pick up a package of sealed envelopes in either of the two groups A or B, Blinding description: The current study is a three-blind randomized clinical trial.So that the participant , researcher and data analyst are not aware of any individuals located in the studied groups and control.Purslan seed and placebo capsules are completely similar in appearance and are prepared and coded by the pharmacist.The researcher is unaware of the code of the capsules and the participants are unaware of the capsule contents due to the similarity of the capsules. 3 Condition 1: After pain delivery. Condition 2: Postpartum hemorrhage. Intervention 1: Intervention group: A capsule of 500 mg of purslane seeds prepared in Department of Pharmacology Mashhad University immediately and then every 8 hours after delivery in the first 24 hours after delivery. Intervention 2: Control group: A 500 mg capsule of starch powder prepared in Department of Pharmacology Mashhad University immediately and then every 8 hours after delivery in the first 24 hours after delivery. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Mahjoobeh Ramezani Motlagh
No.24,Danesh 6 Blvd.,Danesh Ave.
Shirvan Iran (Islamic Republic of) 9461779885 +98 58 3621 0469 rameanimm951@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Golmakani
Mashhad University of Medical Sciences,,Daneshgah Ave
Mashhad Iran (Islamic Republic of) 91388-13944 +98 51 3852 8513 golmakanin@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Being iranian Mother tend to natural delivery Mother's age between the ages of 18 - 35 years Healthy and alive fetus Single pregnancy with cephalic presentation Age Pregnancy 37-42 weeks Normal Body Mass Index(BMI) before or during the first trimester of pregnancy Fetus weight 2500-4000 gram Second to fifth delivery Lack of medical illness No high risk pregnancy No psychiatric illness requiring drug use No regular use of narcotic during pregnancy No history of post partum hemorrhage Is not delivery with medicinal analgesia No use of uterine relaxants during labor No history cesarean section or uterine surgery Is not rapid labor Non-narcotic addiction based on person's statement Natural delivery and without a device No history of uterus or cervical rupture No bleeding in the labor Normal second and third stages of delivery Rupture of the membranes less than 12 hours until delivery Second degree rupture and less perineal No abnormal placenta Non stretch excessive of uterin during pregnancy 18 years 35 years Female Mother suffers from serious complications after delivery Requires additional treatment to control hemorrhage Do not breastfeeding in the third or fourth stages of delivery Using herbal or chemical drugs to relieve pain The mother insisted on early discharge 24 hours after delivery Z39 O72.1 Encounter for maternal postpartum care and examination Other immediate postpartum hemorrhage Treatment - Drugs Treatment - Drugs Intervention group: A capsule of 500 mg of purslane seeds prepared in Department of Pharmacology Mashhad University immediately and then every 8 hours after delivery in the first 24 hours after delivery. Control group: A 500 mg capsule of starch powder prepared in Department of Pharmacology Mashhad University immediately and then every 8 hours after delivery in the first 24 hours after delivery. After pain. Timepoint: During the first 24 hours of delivery - every 8 hours - an hour before and one hour after the intervention. Method of measurement: Measuring instrument for pain, vas scale. Hemorrhage volume. Timepoint: The first 6 hours of delivery - Every one hour . Method of measurement: Chinese digital scales. Mashhad University of Medical Sciences Approved 2018-07-14 Ethics Committee in Mashhad University of Medical Sciences Mashhad University of Medical Sciences.,Daneshgah Ave.,Mashhad.,Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)