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IRCT20180224038846N1 IRCT 2019-02-22 Sanandaj University of Medical Sciences Comparision of the Effect of Vaginal Capsule of Evening Primrose Oil and Misoprostol on Cervical Ripening of Nulliparous Women with Post-term Pregnancy Comparision of the Effect of Vaginal Capsule of Evening Primrose Oil and Misoprostol on Cervical Ripening of Nulliparous Women with Post-term Pregnancy 2639-06-22 anticipated 130 Pending https://irct.ir/trial/29852 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: According to the searches made, No study has been conducted on the effect of evening primrose oil capsules on cervical ripening in post-term women in Sanandaj city and This research will be conducted for the first time in Sanandaj, Randomization description: Patients are randomly assigned to treatment with the toss of a coin, Blinding description: This study will be single blinded.The study consisted of two groups of intervention (Capsule of evening primrose oil and misoprostol) and The control group (Capsule of placebo and misoprostol) and Participants in this study will receive treatment that would be totally unaware. 3 Post Term Pregnancy. Intervention 1: Intervention group: The nulliparous women with post-term pregnancy admitted to maternity ward of Besat hospital with less than 4 Bishop score will be the interventional group. For this group evening primrose oil as a gelatin capsule (500 mg) vaginally will be inserted into posterior fornix and misoprostol 25 micrograms sublingually will be received. Intervention 2: Control group: The nulliparous women with post term pregnancy admitted to maternity ward of Besat hospital with less than 4 Bishop score will be control group. For this group placebo capsule vaginally will be inserted into posterior fornix and 25 micrograms misoprostol sublingually will be received. 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 There is no more information
public Soma Bahmani
Lale 1 Alley-29 Esfsnd Street-Baharan Town- Sanandaj
Sanandaj Iran (Islamic Republic of) 6617853471 +98 87 3377 3306 Soma.bahmani25@gmail.com Sanandaj University of Medical Sciences scientific Soma Bahmani
Lale 1 Alley - 29 Esfand Street - 3/19 - Baharan Town - Sanandaj
Sanandaj Iran (Islamic Republic of) 6617853471 +98 87 3377 3306 Soma.bahmani25@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Healthy nulliparous women Lack of contraindications for the use of evening primrose oil Lack of contraindications for the use of misoprostol 40 weeks and 6 days of gestational age based on the date of the first day of the last menstruation or the first trimester ultrasonography Single pregnancy and live fetus Cephalic presentation Fetal heart rate pattern is normal Absence of uterine contractions Bishop score lower than or equal to 4 Intact membranes 18 years 49 years Female Gestational age below 40 week and 6 days NST nonreactive O48.0 Post-term pregnancy N/A Treatment - Drugs Intervention group: The nulliparous women with post-term pregnancy admitted to maternity ward of Besat hospital with less than 4 Bishop score will be the interventional group. For this group evening primrose oil as a gelatin capsule (500 mg) vaginally will be inserted into posterior fornix and misoprostol 25 micrograms sublingually will be received. Control group: The nulliparous women with post term pregnancy admitted to maternity ward of Besat hospital with less than 4 Bishop score will be control group. For this group placebo capsule vaginally will be inserted into posterior fornix and 25 micrograms misoprostol sublingually will be received. Cervical ripening rate. Timepoint: Every 6 hours as needed up to 3 doses. Method of measurement: In this study, cervical ripening was evaluated based on the evaluation of 5 components (dilatation, effacement, condition and strength and display station of the organ). Bishop score higher than 9 show the highest level of cervical preparation and lower than 4 suggest undesirable cervical status. Sanandaj University of Medical Sciences Approved 2018-03-13 Ethics committee of Kurdistan University of Medical Sciences Kurdestan University of Medical Sciences- Pasdaran Street -Sanandaj Sanandaj Kurdistan Iran (Islamic Republic of)