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IRCT20210127050156N2 IRCT 2021-12-06 Karaj University of Medical Sciences The effect of topical magnesium sulfate on the cervix in the development of labor The effect of topical magnesium sulfate compared with topical normal saline on the cervix in the progression of labor : a randomized clinical trial 2021-12-22 anticipated 200 Complete https://irct.ir/trial/59843 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Pregnant women who consented to participate were randomly selected to receive either Magnesium sulfate or Normal Saline . The block randomization method will be designed by using "www.sealedenvelope.com". The size of blocks is 4, Blinding description: The randomization list will be prepared by the statistician. Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. Completing the final information is the responsibility of the person who is unaware of the type of treatment. The statistician will also be kept blind. 3 labor. Intervention 1: Intervention group:They will received 5 cc magnesium sulfate 50%, topically on the cervix in the latent and also in the active phase of labor. Intervention 2: Control group: They will received 5 cc normal saline, topically on the cervix in the latent and also in the active phase of labor. 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 It is not yet known if there will be a plan to make this available
public Masoumeh Farahani
No.51, Eastern 14 Ave., Northern Allameh Ave., Saadatabad
Tehran Iran (Islamic Republic of) 3149779453 +98 21 2236 5627 m.farahanii@abzums.ac.ir Karaj University of Medical Sciences scientific Masoumeh Farahani
No.51, Eastern 14 Ave., Northern Allameh Ave., Saadatabad
Tehran Iran (Islamic Republic of) 3149779453 +98 21 2236 5627 m.farahanii@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Pregnant woman candidate for vaginal birth primigravid gestational age>= 38 weeks no limit no limit Female Indications for cesarean section include failure to progress, cessation of labor, decreased heart rate, bleeding and cleft palate, placenta abruption , fever, and chorioamnionitis Underlying diseases such as diabetes and hypertension Preeclampsia Eclampsia ---- ---- Treatment - Drugs Placebo Intervention group:They will received 5 cc magnesium sulfate 50%, topically on the cervix in the latent and also in the active phase of labor Control group: They will received 5 cc normal saline, topically on the cervix in the latent and also in the active phase of labor Duration of labor. Timepoint: After delivery. Method of measurement: Stopwatch. Bishop Score changes. Timepoint: Every two hours until delivery. Method of measurement: Score Bishop Curve. Karaj University of Medical Sciences Approved 2021-10-25 Ethics committee of Alborz University of Medical Sciences Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street Karaj Tehran Iran (Islamic Republic of)