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IRCT20200510047377N1 IRCT 2020-06-18 Rasht University of Medical Sciences Effect of intravaginal application of magnesium sulfate on the intensity of labor pain, and the duration of the t first and second stages of labor in nulliparous women referred to Al-zahra hospital magnesium sulfate Effect of intravaginal application of magnesium sulfate on the intensity of labor pain, and the duration of the t first and second stages of labor in nulliparous women referred to Al-zahra hospital: A Clinical Trial 2020-06-24 anticipated 72 Complete https://irct.ir/trial/48742 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, patients receive a written consent form and execution methods and interventions are explained. Then eligible people,They are randomly assigned to two groups by the method of 4 random blocks.These patients are divided into two groups treated with magnesium sulfate the control group. None of the participants in the study will be notified of the randomization list .for concealment practices we use sealed envelopes that are numbered in order And the envelope for each person only after Confirmation of the eligibility criteria for her to enter the study and Signing the consent ,will be opened. Register and randomization will be done by third person, Blinding description: After generating the list, each person is assigned a unique code and during the study the person will be identified with this code. None of the participants in the study will be aware of the randomization list and also to apply allocation concealment randomization, the groups are placed in closed envelopes in the admission section and eligible individuals who enter the study are included respectively.Therefore, the study was double-blind so that patients and outcome evaluation specialist are unaware of the allocation status of the two groups to the study. 3 labor facilitation. Intervention 1: Intervention group:group A, after vaginal examination 10cc of magnesium sulfate 50% will be applied intravaginal on the cervix at the dilatations of 5-6cm,7-8cm 9-10 cm . Intervention 2: Control group: group B will receive normal saline (in the same size and shape) in the same way as group A. 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 planning to share and publish.
public Fatemeh Gholamalipour
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839- 41446 +98 13 3336 9224 Fatemeh.gholamalipour@gmail.com Rasht University of Medical Sciences scientific Dr.fereshteh fakoor
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 fereshtehfakor@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Nullipara women in the active phase of labor Not being PROM Woman between age 18-35, Prime para Single tone cephalic fetus Estimated fetal weight between 2500-4000 gr Low risk pregnancy BMI 19.8 - 30 Not using calcium blocker drugs No drug abuse Pregnancy age 37 to 42 weeks 18 years 35 years Female Infertility history History of dangerous underlying disease History of drug use during pregnancy Polyhydramnios Participate in childbirth preparation classes during pregnancy The presence of any contraindications to natural childbirth O00-O99 ICD-10 Pregnancy, childbirth and the puerperium Treatment - Drugs Treatment - Drugs Intervention group:group A, after vaginal examination 10cc of magnesium sulfate 50% will be applied intravaginal on the cervix at the dilatations of 5-6cm,7-8cm 9-10 cm . Control group: group B will receive normal saline (in the same size and shape) in the same way as group A. The intensity of pain in dilatation is 3-5 cm. Timepoint: The time interval between entering the labor and reaching the dilatation 3-5 cm of the cervix. Method of measurement: visual analogue scale. The intensity of pain in dilatation is 3-5 cm. Timepoint: The time interval between entering the labor and reaching the dilatation 3-5 cm of the cervix. Method of measurement: visual analogue scale. The intensity of pain in dilatation is 7-8 cm. Timepoint: time interval 3-5 until the examination of the cervix 7-8 cm. Method of measurement: visual analogue scale. The intensity of pain in dilatation is 9-10 cm. Timepoint: time interval 7-8 until the examination of the cervix 9-10 cm. Method of measurement: visual analogue scale. Rasht University of Medical Sciences Approved 2020-05-27 Ethics committee of Guilan University of Medical Sciences Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN Rasht Guilan Iran (Islamic Republic of)