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IRCT201205229830N1 IRCT 2014-03-10 Research Council of Mashhad University of Medical Sciences Evaluation of the effect of saffron oral capsules on pain severity and labor duration Evaluation of the effect of saffron oral capsules on pain severity and duration of the active phase of labor first stage 2013-11-06 anticipated 60 Complete https://irct.ir/trial/10367 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A delivery. Intervention 1: Capsules 250 mg of the drug (saffron) every 2 hours and up to 3 doses, the intensity of uterine contractions and the progress of labor is consumed orally by the research unit. Intervention 2: Capsules 250 mg of the pelacebo every 2 hours and up to 3 doses, the intensity of uterine contractions and the progress of labor is consumed orally by the research unit.
public Sedigheh Ahmadi
Mashhsd University Of Medical Sciences
Mashhad Iran (Islamic Republic of) +51 1 8591511 Ahmadis901@mums.ac.irahmadisedigh64@gmail.com.azharis@mums.ac.ir/ azharis@mums.ac.ir Mashhad University of Medical Sciences scientific Sedigheh Azhari
Mashhsd University Of Medical Sciences
Mashhad Iran (Islamic Republic of) +51 1 8591511 Azharis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Completing the written informed consent to participate in the study؛age of 18-35 years; body mass index of 19.5- 30;gestational age of 37-42 weeks; having no history of pregnancy more than 20 weeks of gestation; singleton pregnancy; cervical dilatation of 3-4 cm; cephalic presentation. Exclusion criteria: using any herbal drug during the past 48 hours; addiction or using a variety of tobacco and alcohol; maternal pregnancy complications (preeclampsia, bleeding during pregnancy, threat to abortion, premature rupture of fetus membranes more than 12 hours before admission of mother), having or history of any systemic disease (diabetes, hypertension, heart and kidney disease, etc), history of mental disorder, speaking, hearing and mental disorder, disproportion of maternal pelvic with fetal head; estimated fetal weight less than 2500 g and more than 4000 g (according to Johnson rules); fetal heart rate abnormalities; any abnormalities in the fetus (based on sonography; obstetric problems; multiple pregnancy; previous surgery on the uterus; cervix and delivery canal; cesarean indication; allergic reaction to the saffron 18 years 35 years Female O80.8 Other single spontaneous delivery Placebo Placebo Capsules 250 mg of the drug (saffron) every 2 hours and up to 3 doses, the intensity of uterine contractions and the progress of labor is consumed orally by the research unit Capsules 250 mg of the pelacebo every 2 hours and up to 3 doses, the intensity of uterine contractions and the progress of labor is consumed orally by the research unit Pain intensity of labor. Timepoint: 1 hour intervals during the intervention. Method of measurement: Pain intensity using a visual pain scale. Duration of the active phase of labor first stage. Timepoint: 1-2 hour intervals during the intervention. Method of measurement: During the active phase of labor and vaginal exam registration. Uterine contractions. Timepoint: During each 30-minute intervention. Method of measurement: Tocodynamomtr device and touch the hand. Research Council of Mashhad University of Medical Sciences Approved 2013-06-22 Mashhad University Of Medical Sciences Mashhad University Of Medical Sciences Mashhad Iran (Islamic Republic of)