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IRCT20171015036793N2 IRCT 2018-02-14 vice chancellor for research of the Ahvaz Jundishapour University of Medical Sciences effect of oral and vaginal evening primrose oil on cervical ripening and pregnancy outcomes and compare together the comparison of oral and vaginal evening primrose oil on cervical ripening in late term pregnancy in nulliparous women 2017-07-27 anticipated 90 Complete https://irct.ir/trial/27413 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling will be done in a sequential non-probabilistic manner, which will be selected as a sample from the start of the study for all pregnant women who have the criteria for entering the study and will continue to reach the final sample size. The assignment of participants to each of the study groups will be done randomly by block method using 6 blocks. In this study, 15 blocks of 6 were designed, in each block, the ratio of the presence of 3 groups in these blocks was 2- 2-2 and is equal, Blinding description: In order to blind people in the oral intervention group, the placebo will be used vaginally, and in the vaginal intervention group, the placebo will be used orally. In order to ensure the reduction of the occurrence of information malpractice and the hypnotic effect of drugs, this double-blind, double-blind trial designed to keep both patients and the treatment staff of the type of treatment intended to be kept unaware. N/A complications of labor and delivery. Intervention 1: Intervention group: drug group 1, Oral capsule of 1000 mg of primrose oil and one vaginal gelatin capsule beginning admit participant in delivery room(manufacturing by Barrij essence company). Intervention 2: Intervention group: Drug group 2 (vaginal capsule 1000 mg of evening primrose oil and a gelatin capsule orally). Intervention 3: Control group: Placebo (oral capsule 50 mg gelatin). No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Fatemeh Khatami
Ahvaz Jundishapour University of Medical Sciences, Golestan street, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3336 7543 fatemehkhatami71@gmail.com Ahvaz Jundishapour University of Medical Sciences scientific Shadab Shahali
Ahvaz Jundishapour University of Medical Sciences, Golestan street, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3336 7543 shadabshahali@yahoo.com School of Nursing and Midwifery, Ahvaz Jundishapour University of Medical Sciences Iran (Islamic Republic of) cephalic presentation alive fetus with gestational age 40 weeks to42 weeks based on LMP or ultrasound in first trimester Normal patterns of fetal heart rate Without uterine contractions cervical bishop score less than 4 intact membranous Low-risk pregnancy ( have no known surgical and internal disease or pregnancy complication such as previa, abruption, preeclampsia , no known fetal problems) Avoiding the enema Avoiding the Intercourse 15 years 40 years Female consumption of laxatives, the use of herbal medicines, chemical or traditional methods for induction of labor O61.0 Failed medical induction of labour Treatment - Drugs Treatment - Drugs Placebo Intervention group: drug group 1, Oral capsule of 1000 mg of primrose oil and one vaginal gelatin capsule beginning admit participant in delivery room(manufacturing by Barrij essence company) Intervention group: Drug group 2 (vaginal capsule 1000 mg of evening primrose oil and a gelatin capsule orally) Control group: Placebo (oral capsule 50 mg gelatin) Ripening of cervix. Timepoint: during the labor. Method of measurement: bishop score table. Duration of first, second and third stage of labor. Timepoint: during the labor. Method of measurement: chronometer/examination/check list/observation. Type of delivery. Timepoint: during the labor. Method of measurement: Separation into cesarean section and normal according to how the embryos leave. Infant APGAR score. Timepoint: first and fifth minute after delivery. Method of measurement: apgar table. vice chancellor for research of the Ahvaz Jundishapour University of Medical Sciences Approved 2017-05-22 ethics committee of Ahvaz Jundishapour University of Medical Sciences Ahvaz Jundishapour University of Medical Sciences, Golestan street; Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)