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IRCT20120428009576N5 IRCT 2021-01-18 Qazvin University of Medical Sciences The effect of topical magnesium sulfate on the progression of effacement, dilatation and duration of labor in nullipar women The effect of topical magnesium sulfate on the progression of effacement, dilatation and duration of labor in nullipar women 2020-12-21 anticipated 98 Complete https://irct.ir/trial/53412 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization was performed using a table of random numbers. First, a number of numbers were randomly placed in the table and specified by the researcher to read the numbers from top to bottom in the table, then even numbers were used for intervention A and odd numbers were used for intervention B, Blinding description: Considering that in the intervention group, 10 cc of 50% magnesium sulfate will be applied topically through the vagina using a syringe, In the control group, under the same conditions, only distilled water will be used instead of magnesium sulfate to blind the researcher and the patient. It should be noted that completely identical vials of distilled water and magnesium sulfate will be used without the drug name label. These vials will be separated by a label containing a code, and the researcher is completely unaware of their nature. 3 labor progress. Intervention 1: Intervention group: In the intervention group, after detecting the active phase with dilation of 3-5 cm, 10 cc of 50% magnesium sulfate made by Shahid Ghazi Pharmaceutical Company of Tabriz-Iran with serial number 3138 is poured on the cervix during vaginal examination, so that the whole cervix is impregnated with it. In addition, in order to better absorb the drug, the mother will be asked to stay in bed for half an hour after taking the drug. Intervention 2: Control group: In the control group, after detecting the active phase with dilation of 3-5 cm, 10 cc of distilled water is poured on the cervix during vaginal examination, so that the whole cervix is impregnated with it. In addition, in order to better absorb the drug, the mother will be asked to stay in bed for half an hour after taking the drug. Yes - There is a plan to make this available What will be shared: The collected information is in the form of a questionnaire and is statistically analyzed. When: The start of the access period is one year after the results are published. To whom: For obstetricians and researchers working in academic institutions Conditions: Evaluate the path and process of study and analyze it Where to obtain: For information, refer to Dr. Azin Yazdani. The communication channels are as follows: By sending an email to the address: azin_y6583@yahoo.com or refer and contact Kosar Hospital at the address: Qazvin, Taleghani St. Phone: 028-33236374 Postal address: 34156-13176 How to obtain: After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific response of the study. At your discretion, the requested information will be sent within 10 days after receiving the email. Comments:
public Azin Yazdani
Bahonar Blvd, Qazvin
Qazvin Iran (Islamic Republic of) 3413786313 +98 28 3333 6001 azin_y6583@yahoo.com Qazvin University of Medical Sciences scientific Dr Ezzatalsadat Haji Seid Javadi
Kosar Hospital, Taleghani St., Qazvin
Qazvin Iran (Islamic Republic of) 13176- 34156 +98 28 3323 6374 dr_seidjavadi@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Mother age between 18 until 35 years Being primiparous Full gestational age 37-42 weeks Live single fetus with head display and estimated weight 2500-4000 grams Spontaneous start of the labor process Body mass index 19.8-30 kg per square meter 18 years 35 years Female History of infertility Having risky underlying diseases (heart disease, lung disease, connective tissue and smooth muscle problems, and fetal head incompatibility with the mother's pelvis) Fetal heart rate problems Incidence of placental abruption and umbilical cord prolapse Patient non-cooperation Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, after detecting the active phase with dilation of 3-5 cm, 10 cc of 50% magnesium sulfate made by Shahid Ghazi Pharmaceutical Company of Tabriz-Iran with serial number 3138 is poured on the cervix during vaginal examination, so that the whole cervix is impregnated with it. In addition, in order to better absorb the drug, the mother will be asked to stay in bed for half an hour after taking the drug. Control group: In the control group, after detecting the active phase with dilation of 3-5 cm, 10 cc of distilled water is poured on the cervix during vaginal examination, so that the whole cervix is impregnated with it. In addition, in order to better absorb the drug, the mother will be asked to stay in bed for half an hour after taking the drug. Cervical effacement. Timepoint: At the beginning of the active phase and then every two hours. Method of measurement: Through vaginal examination. Cervical dilatation. Timepoint: At the beginning of the active phase and then every two hours. Method of measurement: Through vaginal examination. Type of delivery. Timepoint: After delivery. Method of measurement: View and record in the file. Duration of labor. Timepoint: Every two hours. Method of measurement: Per second. Apgar score. Timepoint: Every two hours. Method of measurement: In terms of score. Hemoglobin. Timepoint: Six hours after delivery. Method of measurement: Blood test. Postpartum hemorrhage and rupture of the birth canal. Timepoint: After delivery. Method of measurement: Blood tests and examination. Qazvin University of Medical Sciences Approved 2020-12-26 Ethics Committee of Qazvin University of Medical Sciences Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd Qazvin Qazvin Iran (Islamic Republic of)