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IRCT20240429061586N1 IRCT 2026-01-05 Rafsanjan University of Medical Sciences Investigating The effect of plantago capsules on postpartum hemorrhage after normal vaginal delivery Investigating The effect of plantago capsules on postpartum hemorrhage after normal vaginal delivery 2024-09-26 anticipated 80 Complete https://irct.ir/trial/76712 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: thers are placed in one of the two groups of receiving Barhang capsule or control by random allocation, in such a way that the first person takes one of the two balls on which the letter a or b is written, and the next person is in the opposite group and until the end of the sample The acquisition continues in the same way, Blinding description: The participants is not aware of which group they are in, and the data analyst is not aware of which group the data belongs to. Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily, 12 hours apart, for 2 weeks. The cans of medication are coded by the pharmacist. participants and the analyst are unaware of the contents of the cans. 3 postpartum hemorrhage after normal vaginal delivery. Intervention 1: Intervention group:In the intervention group (40 people), starting 24 hours after delivery, two capsules of plantain (containing 750 mg of plantain seed powder obtained by hydroalcoholic method and preserving its astringent compounds) are administered orally daily for 2 weeks. The method of preparing the capsules is as follows: plantain seeds will be obtained from an apothecary in Rafsanjan city. The seeds purchased at the Kerman Faculty of Traditional Medicine are examined by a botanist and after confirming the genus and species name, a herbarium number is assigned to them. In order to initially check the quality of the purchased samples, the amount of total ash, acid-insoluble ash, moisture, and percentage of extract obtained from the plant are determined using the methods mentioned in the herbal pharmacopoeia. To prepare the final product, the plantain seeds are first carefully examined to ensure that they do not contain foreign components or impurities. The seeds will be powdered with an electric grinder. The seed powder is filled into size 2 capsules with a long base using a manual capsule filling machine. Each capsule contains 750 mg of plantain. Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily at 12-hour intervals for 2 weeks. The medicine cans are coded by the pharmacist and the obstetrician and analyst are unaware of the contents of the cans. During 40 days, by forming a group in cyberspace, individuals are followed up daily for taking the medicine and filling out the relevant form and the explanations are reminded again and at the end of this 40-day period, the filled forms are delivered to comprehensive health centers. In the case of samples that are not able to visit health centers, they will also be followed up separately and the forms will be delivered in person. The average days and bleeding score in the two intervention and control groups are evaluated and compared. Intervention 2: Control group:The control group (40 people) receives placebo capsules containing lactose. Lactose-containing capsules are used as placebo. Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily at 12-hour intervals for 2 weeks. The drug cans are coded by the pharmacist, and the nurse and the analyst do not know the contents of the cans. During 40 days, by forming a group in cyberspace, people are followed up daily to take the drug and fill out the relevant form, and the explanations are reminded again, and at the end of this 40-day period, the filled forms are delivered to comprehensive health centers. In the case of samples that are not able to visit health centers, they will also be followed up separately and the forms will be delivered in person. The average days and bleeding score in the two intervention and control groups are evaluated and compared. Yes - There is a plan to make this available What will be shared: In this study, personal information cannot be published, but information about the results and analysis is accessible When: Access starts 7 months after publication To whom: Researchers working in academic institutions and interested students can access the information Conditions: Data can be used by mentioning the source Where to obtain: For people, if they refer to my email, if the request is allowed, an email will be sent within a few days. nargeskhodadadpour1400@yahoo.com How to obtain: It can be accessed by visiting Rafsanjan University of Medical Sciences or a personal email will be sent within a few days if allowed Comments:
public Narges .Khodadadpour
Kargar St
Rafsanjan Iran (Islamic Republic of) 7716648995 +98 34 3425 2173 nargeskhodadadpour1400@yahoo.com Rafsanjan University of Medical Sciences scientific Narges Khodadadpour
Kargar St
Rafsanjan Iran (Islamic Republic of) 7716648995 +98 34 3425 2173 nargeskhodadadpour1400@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Gestation age 37-42 weeks Number of pregnancies less than 3 Having a single embryo and cephalic presentation The weight of the baby is between 2500-4000 grams Absence of pregnancy complications (polyhydramnios, bleeding and pregnancy blood pressure) No history of cesarean section and uterine surgery or postpartum bleeding Not suffering from systemic diseases (diabetes, hypothyroidism, coagulation disorders) Not taking magnesium sulfate during pregnancy Absence of a wide episiotomy (grade 3 and 4 tears) during the second stage of labor The normal length of the first, second and third stage of labor Not using herbal or chemical medicines before delivery and during labor and delivery Severe bleeding during delivery (more than 500 cc) and receiving medical treatment no limit no limit Female Presence of pregnancy complications (polyhydramnios, bleeding and pregnancy blood pressure) history of cesarean section and uterine surgery or postpartum bleeding suffering from systemic diseases (diabetes, hypothyroidism, coagulation disorders) taking magnesium sulfate during pregnancy Presence of a large episiotomy (grade 3 or 4 tear) during the second stage of labor Abnormal length of the first, second, and third stages of labor using herbal or chemical medicines before delivery and during labor and delivery Severe bleeding during delivery (more than 500 cc) and receiving medical treatment Treatment - Drugs Placebo Intervention group:In the intervention group (40 people), starting 24 hours after delivery, two capsules of plantain (containing 750 mg of plantain seed powder obtained by hydroalcoholic method and preserving its astringent compounds) are administered orally daily for 2 weeks. The method of preparing the capsules is as follows: plantain seeds will be obtained from an apothecary in Rafsanjan city. The seeds purchased at the Kerman Faculty of Traditional Medicine are examined by a botanist and after confirming the genus and species name, a herbarium number is assigned to them. In order to initially check the quality of the purchased samples, the amount of total ash, acid-insoluble ash, moisture, and percentage of extract obtained from the plant are determined using the methods mentioned in the herbal pharmacopoeia. To prepare the final product, the plantain seeds are first carefully examined to ensure that they do not contain foreign components or impurities. The seeds will be powdered with an electric grinder. The seed powder is filled into size 2 capsules with a long base using a manual capsule filling machine. Each capsule contains 750 mg of plantain. Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily at 12-hour intervals for 2 weeks. The medicine cans are coded by the pharmacist and the obstetrician and analyst are unaware of the contents of the cans. During 40 days, by forming a group in cyberspace, individuals are followed up daily for taking the medicine and filling out the relevant form and the explanations are reminded again and at the end of this 40-day period, the filled forms are delivered to comprehensive health centers. In the case of samples that are not able to visit health centers, they will also be followed up separately and the forms will be delivered in person. The average days and bleeding score in the two intervention and control groups are evaluated and compared. Control group:The control group (40 people) receives placebo capsules containing lactose. Lactose-containing capsules are used as placebo. Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily at 12-hour intervals for 2 weeks. The drug cans are coded by the pharmacist, and the nurse and the analyst do not know the contents of the cans. During 40 days, by forming a group in cyberspace, people are followed up daily to take the drug and fill out the relevant form, and the explanations are reminded again, and at the end of this 40-day period, the filled forms are delivered to comprehensive health centers. In the case of samples that are not able to visit health centers, they will also be followed up separately and the forms will be delivered in person. The average days and bleeding score in the two intervention and control groups are evaluated and compared. Postpartum hemorrhage after normal vaginal delivery. Timepoint: Checking the amount of bleeding 24 hours after delivery for 40 days. Method of measurement: PBAC form(PBAC Scoring System). Postpartum hemorrhage after normal vaginal delivery. Timepoint: Bleeding rate 24 hours after delivery for 40 days. Method of measurement: PBAC form. Rafsanjan University of Medical Sciences Approved 2024-09-14 Ethics Committee of Rafsanjan University of Medical Sciences Nurse Street Rafsanjan Kerman Iran (Islamic Republic of)