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IRCT20231121060128N1 IRCT 2024-01-01 Zanjan University of Medical Sciences Comparison of the effectiveness of local administration of magnesium sulfate in the latent phase of labor on the improvement of effacement, dilatation, and duration of labor in primiparous and multiparous women Comparison of the effectiveness of local administration of magnesium sulfate in the latent phase of labor on the improvement of effacement, dilatation, and duration of labor in primiparous and multiparous women 2024-01-10 anticipated 75 Complete https://irct.ir/trial/74501 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible people will be selected during regular visits and then will be assigned to two intervention groups and one control group using a random sampling method of 6 blocks. For this purpose, blocks of 6 will be selected using a table of random numbers so that the sample size reaches 75 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: The study will be double-blind. Pregnant women and the person controlling the progress of labor and delivery will not know about the grouping and type of intervention. Examinations and registration of labor progress in the latent phase will be done and recorded every 4 hours by a research associate. 3 Improvement of dilation, effacement of cervix , and labor duration. Intervention 1: Ten cc of 50% magnesium sulfate (up to two doses) will be poured between the fingers on the cervix during the vaginal examination during the latent phase of labor to cover the entire cervix. During the first half hour after using the medicine, the mother will be asked to rest on the bed in order to better absorb the medicine. In case of rupture of the fetal membranes during or less than half an hour after the local use of the drug, 10 cc of magnesium sulfate will be used again after the end of active shedding. Intervention 2: During the latent phase of labor, ten cc of distilled water (up to two doses) will be poured between the fingers on the cervix during the vaginal examination to cover the entire cervix. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Zahra Rahmi
Gavazang Boulevard, Ait Mousavi Hospital, Zanjan
Zanjan Iran (Islamic Republic of) 56183-45139 +98 24 3313 0000 z.rahemi@yahoo.com Zanjan University of Medical Sciences scientific Hamida Gholami
Gavazang Boulevard, Ayatollah Mousavi Hospital, Zanjan
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3315 6319 gholami@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Singleton pregnancy Cephalic presentation Gestational age, 37-42 weeks Dilatation less than 3 cm Body mass index between 19.8 and 30 kg/m2 Low risk pregnancy 18 years 45 years Female The infertility treatments in a recent pregnancy Multiple pregnancy History or heart disease in recent pregnancy Having a history of severe allergy to magnesium sulfate The existence of contraindications for natural childbirth, including fetal heart rate disorders, placental abruption, umbilical cord prolapse known pelvic stenosis disorder before the start of labor Treatment - Drugs Treatment - Drugs Ten cc of 50% magnesium sulfate (up to two doses) will be poured between the fingers on the cervix during the vaginal examination during the latent phase of labor to cover the entire cervix. During the first half hour after using the medicine, the mother will be asked to rest on the bed in order to better absorb the medicine. In case of rupture of the fetal membranes during or less than half an hour after the local use of the drug, 10 cc of magnesium sulfate will be used again after the end of active shedding. During the latent phase of labor, ten cc of distilled water (up to two doses) will be poured between the fingers on the cervix during the vaginal examination to cover the entire cervix. Cervical effacement, dilation, and duration of labor. Timepoint: Before the intervention, 4 hours and then 8 hours after the intervention. Method of measurement: Vaginal examination. Hemoglobin and hematocrit. Timepoint: 24 hours after delivery. Method of measurement: blood test. Zanjan University of Medical Sciences Approved 2023-11-14 Ethics committee of Zanjan University of Medical Sciences Azadi Square, Central Building of Zanjan University of Medical Sciences, The first floor of the vice-chancellor for research and technology, Zanjan University of Medical Sciences, Zanjan Zanjan Zanjan Iran (Islamic Republic of)