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IRCT20171210037807N1 IRCT 2018-04-27 Sanandaj University of Medical Sciences Effect of honey saffron syrup on the progress of labor in nulliparous women Effect of honey saffron syrup on the progress of labor in nulliparous women admitted to childbirth ward of Imam Khomeini Hospital of Divandarreh in 2018 2018-04-03 anticipated 90 Complete https://irct.ir/trial/30055 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: Using envelopes in the package will be allocated to three groups, Blinding description: Syrups will be shed in dishes of similar shape and color and the color of the syrups is the same in the three groups and encoded by the pharmacist. The codes will be provided to the supervisor only so the researcher and the research units will be unaware of the codes. 3 Childbirth. Intervention 1: Intervention group: Syrup prepared as a solution of 750 mg of saffron and 75 g of honey plus 450 ml of water. Intervention 2: Intervention group: Syrup prepared as a combination of 750 mg of saffron and artificial sugar (15 g sodium saccharin) with 450 ml of water. Intervention 3: Control group: Syrup with the same color as intervention wedges and no calories. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public roonak shahoie
Pasdaran Street
Sanandaj Iran (Islamic Republic of) 666147 - 13446 +98 87 3366 4664 rshaho@gmail.cpm Sanandaj University of Medical Sciences scientific Roonak Shahoie
Pasdaran Street
Sanandaj Iran (Islamic Republic of) 666147 - 13446 +98 87 3366 4664 rshaho@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age 35-18 years nulliparous Gestational age 38-41 weeks Spontaneous labor Estimated estimated fetal weight by the examiner or ultrasound of 2500 - 4000 grams Cephalic presentation Singleton The body mass index is 19.8 - 30 kg / m2 Reactive non-stress test The mother did not use oral and insulin glucose lowering drugs, anti-coagulants, nonsteroidal anti-inflammatory drugs, hypotensive drugs and drugs, benzodiazepines, barbiturates, narcotics, antidepressants, and alcohol. Willing to participate in the study 18 years 35 years Female History of surgery on the uterus, cervix and delivery duct There are indications for cesarean section (abrupt, lack of progress, meconium, narrow pelvis, fetal distress) Fetus to any abnormalities, growth restriction and cardiovascular disease (fetus) Saffron sensitivity History of or mental illness, speech, hearing, visual and mental problems, mother's involvement in chronic and systemic diseases including increased blood pressure, diabetes, respiratory, cardiovascular, liver and endocrine diseases rupture of membranes more than 12 hours mother not willing to contine the study Treatment - Drugs Treatment - Drugs Placebo Intervention group: Syrup prepared as a solution of 750 mg of saffron and 75 g of honey plus 450 ml of water Intervention group: Syrup prepared as a combination of 750 mg of saffron and artificial sugar (15 g sodium saccharin) with 450 ml of water Control group: Syrup with the same color as intervention wedges and no calories First stage of labor. Timepoint: The length of the first stage of labor, from 4 cm to 10 cm dilatation. Method of measurement: Timer. Second stage of labor. Timepoint: The length of the second stage of labor from 10 cm dilatation to the exit of the embryo head. Method of measurement: timer. Third stage of labor. Timepoint: Third stage of labor from exit of newborn to exit of placenta. Method of measurement: timer. Sanandaj University of Medical Sciences Approved 2018-03-14 Ethics committee of kurdistan University of Medical Sciences Pasdaran street Sanandaj Kurdistan Iran (Islamic Republic of)