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IRCT20220219054064N1 IRCT 2022-03-06 Yasouj University of Medical Sciences The effect of nifedipine and indomethacin on pregnant women The effect of nifedipine and indomethacin on the number of uterine contractions, CRP and white blood cell count in pregnant women with idiopathic preterm labor 2022-02-25 anticipated 64 Complete https://irct.ir/trial/62107 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization tool: Due to the small number of samples (32 people in each group), the dice throwing method is used to randomly assign people to two groups.In this way, for each person who enters the clinic or office, he is assigned to one of the treatment groups based on chance. This will continue until the samples are completed in each group, Blinding description: The data analyzer does not know the treatment groups of the study and in the data sent to the analyzer, the names of arbitration A and drug B are used. This study is a blind clinical trial. 3 Condition 1: Differences in the number of white blood cells. Condition 2: Elevated C-reactive protein (CRP). Intervention 1: Intervention group: In the indomethacin group (n = 32), 50-mg oral capsules will be administered as the initial dose and then every 50 mg oral capsule every 8 hours for 48 hours, and the maximum dose in 24 hours should not exceed 200 mg. (Country Protocol). Intervention 2: Intervention group: In the nifedipine group (n = 32), nifedipine 10 mg (one capsule) capsules are given in the first dose, then 20 minutes later, the second dose of 10 mg, then 10 mg every 4 to 6 hours to 48 hours. Yes - There is a plan to make this available What will be shared: Unidentifiable personal data of the study participants will be provided to the Vice Chancellor for Research of Yasouj University of Medical Sciences. When: Start the access period after printing the results To whom: Only researchers working in academic institutions can apply for the data Conditions: In order to conduct secondary studies Where to obtain: Dr. Hossein Mari Ariad oryad.hossein@yums.ac.ir How to obtain: Official request from the Vice Chancellor for Education, Research and Technology of Yasouj University of Medical Sciences Comments:
public Erfan zarhe
Yasuj - Motahhari Blvd. - University of Medical Sciences - Deputy of Education, Research and Technology
Yasuje Iran (Islamic Republic of) 7591741417 +98 74 1333 7251 lahze007@gmail.com Yasouj University of Medical Sciences scientific Parvin Alsadat Eslamnik
Motahhari Blvd., University of Medical Sciences, Vice Chancellor for Education, Research and Technology
Yasouj Iran (Islamic Republic of) 7591741417 +98 74 3334 6070 pnghaffari@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) 26-34 weeks gestational age confirmed by NLO and first trimester ultrasound Contractions of four numbers in 20 minutes or eight in 60 minutes Cervical dilatation equal to or more than 1 cm and cervical effusion 50% or more no limit no limit Female Inflammatory diseases, autoimmune, infectious, multiple, hypertension, diabetes, cervical insufficiency, bladder rupture, vaginal bleeding, fetal death or fetal malignancy, KWFT, history of trauma, cirrhosis, dilatation, cirrhosis Maternal, known uterine abnormalities (with a history or ultrasound), smoking history, history of taking any medication other than the usual supplements during pregnancy, tuberculosis, intrauterine polycystic ovary syndrome, ulcerative colitis Maternal and fetal HJT, previous tocolytic use in the same pregnancy and mothers for whom continuing pregnancy for medical reasons is dangerous and blood pressure less than 50.90 mm Hg D72 R79.82 Other disorders of white blood cells Elevated C-reactive protein (CRP) Treatment - Drugs Treatment - Drugs Intervention group: In the indomethacin group (n = 32), 50-mg oral capsules will be administered as the initial dose and then every 50 mg oral capsule every 8 hours for 48 hours, and the maximum dose in 24 hours should not exceed 200 mg. (Country Protocol). Intervention group: In the nifedipine group (n = 32), nifedipine 10 mg (one capsule) capsules are given in the first dose, then 20 minutes later, the second dose of 10 mg, then 10 mg every 4 to 6 hours to 48 hours. Reactive Protein Test. Timepoint: The measurement is performed on the first day after delivery. Method of measurement: Blood test and use of photometric analyzer. Number of uterine contractions. Timepoint: In the first 2 hours after administration of the drug, it will be checked every 15 minutes and if controlled, every 4-6 hours. Method of measurement: See the number of contractions. Number of white blood cells. Timepoint: The first day after delivery. Method of measurement: CBC DIFF. Yasouj University of Medical Sciences Approved 2021-09-07 Ethics Committee of Yasouj University of Medical Sciences Shahid Motahari Blvd. - Yasouj University of Medical Sciences Yasouj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)