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IRCT201603243860N24 IRCT 2016-12-09 Vice Chancellor for research of Shahid Beheshti University of Medical Sciences Evaluation of Saffron capsule on cervical ripening. Evaluation of Saffron capsule on cervical ripening, beginning and delivery outcomes in primiparous women 2016-04-20 anticipated 100 Complete https://irct.ir/trial/3990 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The random allocation is done using random numbers table and sealed envelope. 2 cervical ripening. Intervention 1: Intervention group: 3 Saffron oral capsules (250 mg) are prescribed and patients should take one capsule every 24 hours for 3 days. These capsules are produced in Shahid Beheshti pharmacy faculty. Intervention 2: Control group: Placebo capsule containing 250 mg of lactose powder that have been prepared under the supervision of pharmacist. Three oral capsules are prescribed and patients should take one capsule every 24 hours (daily) for 3 days. These capsules are produced in Shahid Beheshti pharmacy faculty.
public Giti Ozgoli
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8820 2512 g.ozgoli@gmail.com School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences scientific Giti Ozgoli
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
Tehran Iran (Islamic Republic of) 00 g.ozgoli@gmail.com School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: primiparous woman; age between 18 to 35 years; gestational age of 40 weeks or more; singleton pregnancy with cephalic presentation; not starting uterine contraction; Bishop score less than or equal 4; intact amniotic sac; normal pattern of fetal heart rate; reactive non-stress test; fetal weight between 2500 to 4000; low-risk pregnancy (without known surgical diseases and internal disease or pregnancy complications such as preeclampsia, placental abruption, previa and the absence of known fetal problems); avoiding the use of herbal medicines, chemical or traditional methods for induction of labor in 36 hours before treatment; lack of sex from 24 hours before the beginning till end of the study. Exclusion criteria: Use of oral Saffron; cephalo-pelvic disproportion; using uterine stimulant drugs during the study, such as castor oil; obstetric emergency cases. 18 years 35 years Female O62.0 Primary inadequate contractions Treatment - Drugs Placebo Intervention group: 3 Saffron oral capsules (250 mg) are prescribed and patients should take one capsule every 24 hours for 3 days. These capsules are produced in Shahid Beheshti pharmacy faculty. Control group: Placebo capsule containing 250 mg of lactose powder that have been prepared under the supervision of pharmacist. Three oral capsules are prescribed and patients should take one capsule every 24 hours (daily) for 3 days. These capsules are produced in Shahid Beheshti pharmacy faculty. Cervical ripeningat. Timepoint: Before the intervention, three days later. Method of measurement: Bishop score table. Duration and frequency of uterine contractions per hour. Timepoint: During 3 days after starting intervention. Method of measurement: Observation and physical exam. Mode of delivery. Timepoint: After intervention. Method of measurement: observation. Duration of the first stage of labor (in minutes). Timepoint: After finishing the first stage of labor. Method of measurement: Patient record. Duration of the second stage of labor (in minutes). Timepoint: After finishing the second stage of labor. Method of measurement: Observation and physical exam. Duration of the third stage of labor (in minutes). Timepoint: After finishing the third stage of labor. Method of measurement: Observation and physical exam. Vice Chancellor for research of Shahid Beheshti University of Medical Sciences Approved 2016-04-17 Ethics committee of International Branch of Behesti University of Medical Sciences and Health Servi International Branch of Behesti University of Medical Sciences, No.19, Next to the Hemmat bridge, Shahid Abbaspoor St, Vali Asr St(tavanir), Tehran, Iran. Tehran Iran (Islamic Republic of)