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IRCT20230522058253N1 IRCT 2023-06-16 Hamedan University of Medical Sciences A comparative study of the effect of evening primrose, EASI mechanical method and misoprostol in Natural Vaginal Delivery Comparison of frequency of Natural vaginal delivery after preparation of cervix with evening primrose, EASI mechanical method and misoprostol in 41 week pregnant women 2023-07-23 anticipated 420 Complete https://irct.ir/trial/70419 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be consulted upon entering the hospital and informed consent will be obtained from the patient. After entering the delivery room, they undergo a vaginal examination and Bishop's score is calculated, and then they are included in one of the three groups randomly. Randomization is done by writing the letters A, B and C on three sheets and putting them in a box, and one of these sheets is taken out by the researcher for each patient. After completion, again for the next three patients, sheets will be removed with this random method until we reach the desired sample size. 3 Comparison of frequency of Natural vaginal delivery after preparation of cervix with evening primrose, EASI mechanical method and misoprostol in 41 wee. Intervention 1: Intervention group1: in the evening primrose group, one 1000 mg evening primrose capsule from Dana Pharmaceutical Company is prescribed vaginally every hour. Evening primrose is used until the beginning of the active phase of labor (exam 3-4 cm). Intervention 2: Intervention group2: In the mechanical group, using the Extra amnionic saline infusion method, a Foley cervical catheter is inserted and 30 cc of normal saline is injected per hour, and after the balloon is inserted, the balloon is allowed to come out for a maximum of 12 hours. Intervention 3: Intervention group3: Misoprostol suppository 25 micrograms is placed vaginally. 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 Decisions are made together with other authors.
public Sima Kamkar
Pastaran Ave
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3828 3939 sima_kamkari@yahoo.com Hamedan University of Medical Sciences scientific Sima Kamkar
Pastaran Ave
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3828 3939 sima_kamkari@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Primiparous women at 41 weeks are candidates for termination of pregnancy by natural delivery method no limit no limit Female Pregnant women with IUFD, SGA, IUGR Pregnant women with spotting and abnormal placenta Treatment - Drugs Treatment - Devices Treatment - Drugs Intervention group1: in the evening primrose group, one 1000 mg evening primrose capsule from Dana Pharmaceutical Company is prescribed vaginally every hour. Evening primrose is used until the beginning of the active phase of labor (exam 3-4 cm). Intervention group2: In the mechanical group, using the Extra amnionic saline infusion method, a Foley cervical catheter is inserted and 30 cc of normal saline is injected per hour, and after the balloon is inserted, the balloon is allowed to come out for a maximum of 12 hours. Intervention group3: Misoprostol suppository 25 micrograms is placed vaginally. Bishop's scoring system. Timepoint: Two hours after using misoprostol and the EASI mechanical method and evening primrose. Method of measurement: Bishop's scoring system to check cervix inducibility. Hamedan University of Medical Sciences Approved 2023-01-28 Ethics committee of hamadan University of Medical Sciences Fatemieh hospital, Pastaran Ave. hamadan Hamadan Iran (Islamic Republic of)