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IRCT201212233706N19 IRCT 2013-03-17 Research deputy of Tabriz university of medical sciences The effect of oral Crocus Sativus (Saffron) tablet on cervical ripening in pregnant women with gestational age of 39-41 weeks The effect of oral Crocus Sativus (Saffron) tablet on cervical ripening in term pregnant women: a randomized controlled trial 2013-03-27 anticipated 50 Complete https://irct.ir/trial/3810 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Cervical ripening. Intervention 1: Intervention group: Receiving 3 doses of oral 250 mg saffron tablets each 8 hours. Intervention 2: Control group: Receiving 3 doses of oral 250 mg placebo tablets each 8 hours.
public Sadi Roghaieh
Faculty of Nursing and Midwifery, South Shariati
Tabriz Iran (Islamic Republic of) +98 41 1233 0190 r.sadi65@gmail.com Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh Charandabi
Faculty of Nursing and Midwifery, South Shariati
Tabriz Iran (Islamic Republic of) +98 41 1477 2699 alizades@tbzmed.ac.ir smoalch@yahoo.com Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Women with 1-3 gravidity and gestational age of 39-41 weeks 2. Not starting uterine contractions 3. Willing to deliver in Bonab hospital 4. Secondary and higher educational level 5. Bishop score of four or less 6. Singleton pregnancy 7. Cephalic presentation 8. Intact amniotic sac 9. Reactive non-stress test 10. Estimated fetal weight of 2500 to 4000 grams by ultrasound or examination. Exclusion criteria: 1. History of cryotherapy or cautery of the cervix 2. History of cesarean or having any indication for cesarean section in current pregnancy 3. Diagnosed fetal anomalies 4. Cephalo-Pelvic Disproportion 5. Any known placental problem (placenta previa, placental abruption, placental insufficiency) 6. Maternal infection and systemic chronic diseases, including respiratory diseases, cardio - vascular, endocrine and... 7. Using any of the following drugs by the woman (oral hypoglycemic agents and insulin, anticoagulants such as aspirin and Warfarin ,non steroidal -anti-inflammatory drugs such as ibuprofen and naproxen, herbal drugs and antihypertensives, benzodiazepines such as lorazepam and diazepam, barbiturates such as phenobarbital, narcotics, antidepressant, Alcohol) 8. Not access to telephone line 18 years 39 years Female O62.0 Primary inadequate contractions Treatment - Drugs Placebo Intervention group: Receiving 3 doses of oral 250 mg saffron tablets each 8 hours Control group: Receiving 3 doses of oral 250 mg placebo tablets each 8 hours Bishop score. Timepoint: Befor intervention, at the time of onset of uterin contractions, 10-12 and 20-24 hours after intervention or at the time of doing other treatment interventions. Method of measurement: The Bishop rating system. Duration of the first stage of labor. Timepoint: After finishing the first stage of labor. Method of measurement: Patient record. Interval of onset of uterine active contractions and starting intervention. Timepoint: In the 24 hours after starting intervention. Method of measurement: Patient and clinician report. Duration of the second stage of labor (in minutes). Timepoint: After finishing the second stage of labor. Method of measurement: Observation and physical exam. Need to induce labor. Timepoint: Between admission in delivery room and delivery. Method of measurement: According to hospital records. Delivery type. Timepoint: After delivery. Method of measurement: According to hospital records. Vaginal delivery in 24 hours after starting intervention. Timepoint: 24 hours after intervention. Method of measurement: According to hospital records. Amount of hemorrhage. Timepoint: The time of admission in delivery room and 12 hours after delivery. Method of measurement: Hematocrit assessment. Research deputy of Tabriz university of medical sciences Approved 2013-02-18 Research deputy, Tabriz University of Medical Sciences Golgasht street Tabriz Iran (Islamic Republic of)