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IRCT20180101038176N1 IRCT 2018-03-03 Shahid Beheshti University of Medical Sciences Comparison of effects of misoprostol with evening primrose on ripening of the cervix in nulliparous women Comparison of effects of vaginal misoprostol tablet with vaginal evening primrose capsule on ripening of the cervix in nulliparous women 2018-03-12 anticipated 90 Complete https://irct.ir/trial/28696 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study units is divided into two groups by simple random method in two groups: misoprostol and evening primrose. a 90- pocket box is placed , each of the pockets is assigned to one of the two groups of misoprostol and evening primrose by random number table. The first person removes the pocket number 1, and next members will remove the pockets in their order numbers and assign them to the groups, Blinding description: Eligible participants are kept blind to being assigned to dedicate study groups. It is explained to those who are in one of the two groups of misoprostol and evening primrose, but they do not know which group they are. N/A ripening of the cervix. Intervention 1: The evening primrose group, 1000 mg capsule of evening primrose Vaginal, from the 40th week of gestation, is given one day per day for one week and Placed by the researcher in their cervix. Intervention 2: Control group:The misoprostol group will be given the vaginal misoprostol tablet that will be supervised and ordered by a gynecologist in hospital based on a 25-microgram (one-eighth vaginal tablet 200 micrograms) dose from the 40th week of pregnancy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not starting the study
public Narges Mirzade
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2512 nargesmirzade@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Zohre Sheikhan
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 34 4431 2232 zsheikhan@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 18-35 years old First pregnancy Singleton pregnancy Presentation of fetal cephalic Live fatal Gestational age 40 weeks based on the first day of the last menstruation and first trimester Medical ultrasound Natural pattern of fetal heartbeat No uterine contractions Bishop score less than 4 Healthy amniotic bag Mother's height is more than 150 cm BMI less than 30 Not having drug abuse Natural biophysical profiling test at the time of starting the study Having an ultrasound for pair grading (zero and one Grade) Estimated fetal weighing 2500-4000 gr based on manual examination of the abdomen or ultrasound Low risk pregnancy (Not suffering from known internal and surgical diseases and complications of pregnancy such as previa, abruption, preeclampsia, and the absence of known fetal problems) No vaginal examination a 24 hours before starting the study Avoid doing enema, sexual intercourse, laxative, herbal medicines including castor oil and homeopathic remedies, chemotherapy, breast stimulation and traditional methods of initiating Birth pain 24 hours before the start of study until the end 18 years 35 years Female Any problems that require emergency action, such as not moving the fetus, mother's bleeding Get any herbal medicine during the study period Intercourse during the study possible side effects of the drug Cancellation of participation in the study at each stage Treatment - Drugs Treatment - Drugs The evening primrose group, 1000 mg capsule of evening primrose Vaginal, from the 40th week of gestation, is given one day per day for one week and Placed by the researcher in their cervix. Control group:The misoprostol group will be given the vaginal misoprostol tablet that will be supervised and ordered by a gynecologist in hospital based on a 25-microgram (one-eighth vaginal tablet 200 micrograms) dose from the 40th week of pregnancy Ripening of the cervix. Timepoint: since the onset of intervention and labor. Method of measurement: Bishop's Scoreboard. Shahid Beheshti University of Medical Sciences Approved 2017-10-09 Ethics committee of shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Velenjak St., Shahid Chamran Highway, Tehran, Iran tehran Tehran Iran (Islamic Republic of)