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IRCT20201024049128N3 IRCT 2021-08-09 Alborz University of Medical Sciences Effects of topical magnesium sulfate on progression of labor Evaluating the effects of topical magnesium sulfate on the active phase and progression of labor in nulliparous women 2021-08-06 anticipated 148 Complete https://irct.ir/trial/56162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are recruited in from referred clientele of Kamali hospital that have inclusion criteria. using the randomized block method, in the form of quadruple blocks in two double-blind intervention groups And control will be assigned. In this way, a part of the table of random numbers is selected and AB code is used for 0 to 4 numbers and BA code is used for 5 to 9 numbers. In this study, code A represents the group receiving magnesium sulfate and code B represents the control group. This randomization are done with Random number generator command of STATA software until reaching determined sample size . In this special randomized study people are categorized in control and study group with technique of Balanced block randomization, Blinding description: In order to prepare patient's randomly allocated successions, it was placed in sealed envelopes that are designated in 5 digit serial numbers, by a third person who is not involved in the trial. All the envelopes carry this 5 digit serial number and are opened immediately after completion of patient's work-up and basic lab tests and thus categorize them into intervention and control groups. No patient is aware of another's progression or outcome. 2-3 Active phase and progression of Labor in nulliparous women. Intervention 1: Intervention group: In the intervention group, after the onset of the active phase, which is dilated 3-5 cm with active uterine contractions and having a Bishop score of 5, the researcher pours 10 cc of 50% magnesium sulfate into the cervix from the fingertips with a 10 cc syringe by the examiner. If a ruptured bladder is seen, 10 cc of magnesium sulfate is poured on the cervix again. Generic drug used is magnesium sulfate injection parenteral 10 % 50milliliter (infu-magnesol); made by shahid ghazi pharmaceuticals company; IRC 6210969267810048. Intervention 2: Control group : we perform no special intervention on them just measure the above mentioned factors without magnesium sulphate.Then the data are comprised with the data of intevention group after entering in the analyzing program. 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 Reza Rakhshafar
Kamali Hospital; Kamali Alley; Shohada Square; Shahid Beheshti Street
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3222 2021 rakhshafar.reza@gmail.com Alborz University of Medical Science scientific Bita Badehnoosh
Kamali Hospital; Kamali Alley; Shohada Square; Shahid Beheshti Street
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3222 2021 b_badehnoosh@yahoo.com Alborz University of Medical Sciences Iran (Islamic Republic of) Pregnant women with gestational age of 37 to 42 weeks First labor Single fetus weighting between 3.5 - 4 kg Low risk, non-induced labor BMI of the mother being between 19.8 and 30 kg/m2 18 years 35 years Female Any sign indicating fetal heart rate abnormalities, placenta abruption, cord prolapse or anything that pregnancy is high risk Cephalopelvic disproportion Mothers' chronic underlying disease like anemia, hemophilia, cardiopulmonary or neuromuscular disease Any sign of allergy or toxicity caused by magnesium sulfate Treatment - Drugs Treatment - Other Intervention group: In the intervention group, after the onset of the active phase, which is dilated 3-5 cm with active uterine contractions and having a Bishop score of 5, the researcher pours 10 cc of 50% magnesium sulfate into the cervix from the fingertips with a 10 cc syringe by the examiner. If a ruptured bladder is seen, 10 cc of magnesium sulfate is poured on the cervix again. Generic drug used is magnesium sulfate injection parenteral 10 % 50milliliter (infu-magnesol); made by shahid ghazi pharmaceuticals company; IRC 6210969267810048. Control group : we perform no special intervention on them just measure the above mentioned factors without magnesium sulphate.Then the data are comprised with the data of intevention group after entering in the analyzing program. Fetal station. Timepoint: Every 2 hours until the end of active phase of labor. Method of measurement: Physical examination and recording the data on questionnaire. Cervical dilation. Timepoint: Every 2 hours until the end of active phase of labor. Method of measurement: Physical examination and recording the data on questionnaire. Cervical effacement. Timepoint: Every 2 hours until the end of active phase of labor. Method of measurement: Physical examination and recording the data on questionnaire. Cervical consistency. Timepoint: Every 2 hours until the end of active phase of labor. Method of measurement: Physical examination and recording the data on questionnaire. Cervical position. Timepoint: Every 2 hours until the end of active phase of labor. Method of measurement: Physical examination and recording the data on questionnaire. Bishop score. Timepoint: Every 2 hours until the end of active phase of labor. Method of measurement: Calculated by adding up the scores of the first 5 variables, maximum score of15. Length of the active phase of labor. Timepoint: Every 2 hours until the end of active phase of labor. Method of measurement: Physical examination and recording the data on questionnaire. Alborz University of Medical Sciences Approved 2021-03-08 Ethics Committee of Alborz University of Medical Sciences Research and Development Department of Alborz University of Medical Sciences, Safarian Ave, 45 Metri Blvd, Karaj, Iran Karaj Alborz Iran (Islamic Republic of)