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IRCT20210105049944N1 IRCT 2021-03-06 Ahvaz University of Medical Sciences The effectiveness of magnesium sulfate vaginal gel on cervical ripening and induction of labor in nulliparous women The effectiveness of magnesium sulfate vaginal gel on cervical ripening and induction of labor in nulliparous women: a randomized controlled clinical trial 2021-04-19 anticipated 174 Complete https://irct.ir/trial/54273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To determine the allocation sequence, 3 and 6 blocking methods with 1: 1 allocation ratio are used. After listing almost all possible states of the blocks and assigning a number to each of them, the assignment sequence will be determined using a computer random number table (using WWW.Randomizer.org). The randomization list is prepared by a statistician. To conceal the type of intervention, it is written on paper and numbered in a series of sealed opaque matte envelopes. By attending the study hospital, the researcher will open an envelope for each research sample in the order of their numbers and the type of intervention will be determined, Blinding description: Placebo is used in the same shape and packaging as magnesium sulfate gel. Pregnant women and medical staff are kept unaware of the type of treatment provided. 2-3 Cervical ripening and induction of labor. Intervention 1: Intervention group: The first group receives magnesium sulfate vaginal gel containing 6 grams of magnesium sulfate prepared by the Industrial Laboratory of the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. Participants receive the gel as soon as they are admitted and all participants are examined 4 hours later. If there is no change, another dose of the same intervention is performed and re-examined 4 hours later. Intervention 2: Intervention group: The second group receives magnesium sulfate vaginal gel containing 4 grams of magnesium sulfate prepared by the Industrial Laboratory of the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. Participants receive the gel as soon as they are admitted and all participants are examined 4 hours later. If there is no change, another dose of the same intervention is performed and re-examined 4 hours later. Intervention 3: Control group: The third group received a placebo containing the same materials used in magnesium sulfate vaginal gel except magnesium sulfate in a similar shape and package prepared by the Industrial Laboratory of the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. Participants receive the gel as soon as they are admitted and all participants are examined 4 hours later. If there is no change, another dose of the same intervention is performed and re-examined 4 hours later. 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 Zahra Chenari
Esfand Ave, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8331 chenari.z@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr.Mina Iravani
Esfand Ave, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8331 iravani-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Desire to participate in the study Being nulliparous Mother age 18-40 years Body mass index 18.5-25 Post date gestational age Bishop score less than 4 Single fetus with cephalic presentation and intact membranes Estimated weight of the fetus 2500-4000 grams Low risk pregnancy Indication of labor induction 18 years 40 years Female Risky underlying disease (anemia, blood disorders, heart or lung disease, connective tissue and smooth muscle problems) History of any uterine scar Refer with bleeding or rupture of membranes Multiple pregnancy Diagnosis of cephalopelvic disproportion by a physician Contraindications to use of magnesium sulfate Patient non-cooperation Treatment - Drugs Treatment - Drugs Placebo Intervention group: The first group receives magnesium sulfate vaginal gel containing 6 grams of magnesium sulfate prepared by the Industrial Laboratory of the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. Participants receive the gel as soon as they are admitted and all participants are examined 4 hours later. If there is no change, another dose of the same intervention is performed and re-examined 4 hours later. Intervention group: The second group receives magnesium sulfate vaginal gel containing 4 grams of magnesium sulfate prepared by the Industrial Laboratory of the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. Participants receive the gel as soon as they are admitted and all participants are examined 4 hours later. If there is no change, another dose of the same intervention is performed and re-examined 4 hours later. Control group: The third group received a placebo containing the same materials used in magnesium sulfate vaginal gel except magnesium sulfate in a similar shape and package prepared by the Industrial Laboratory of the Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. Participants receive the gel as soon as they are admitted and all participants are examined 4 hours later. If there is no change, another dose of the same intervention is performed and re-examined 4 hours later. Average of Bishop score. Timepoint: Before the intervention, 4 hours after the intervention, 8 hours after the intervention. Method of measurement: Vaginal examination, Bishop score table. The length of labor. Timepoint: End of the study. Method of measurement: Partograph form. Probable complications of magnesium sulfate. Timepoint: 4 hours after the start of the intervention, 8 hours after the start of the intervention. Method of measurement: Questionnaire. Number of doses of misoprostol used. Timepoint: End of the study. Method of measurement: Hospital file. Type of delivery. Timepoint: End of the study. Method of measurement: Hospital file. Number of doses of oxytocin used. Timepoint: End of the study. Method of measurement: Hospital file. Duration of hospitalization of mother. Timepoint: End of the study. Method of measurement: Hospital file. APGAR score of the first and fifth minutes. Timepoint: End of the study. Method of measurement: Hospital file. Ahvaz University of Medical Sciences Approved 2021-02-13 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Esfand Ave, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)