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IRCT20240111060683N1 IRCT 2024-02-12 Gonabad University of Medical Sciences The effect of an additional dose of vitamin D3 supplementation on the rate of cessation and recurrence of preterm labor in women referred to the hospital The effect of an additional dose of vitamin D3 supplementation on the rate of cessation and recurrence of preterm labor in women referred to the hospital 2024-02-10 anticipated 68 Complete https://irct.ir/trial/74998 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Sampling will be non-random (available) and for random allocation of samples to each of the 2 intervention and control groups, blocks of 4 variables will be used. In this way, first 6 possible states of blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) are listed and a number from 1 to 6 is assigned to each block. Then, a number between 1 and 6 is randomly selected and then people are assigned to the vitamin D (B) supplement group and the control group (A) based on the block corresponding to the selected number. This work continues until the sample volume is completed, Blinding description: Blinding in this study is the person who conducts the vitamin D level test, because she does not know which group she is conducting the test. 3 The effect of an additional dose of vitamin D3 supplement on the rate of cessation and recurrence of premature labor in women referred to Bahlul Gonabad and Vali Asrbirjand hospitals 1402. Intervention 1: In the intervention group, an additional dose of 1000 units of vitamin D (2000 units in total) will be prescribed to the intervention group for a maximum of one week after the onset of premature labor symptoms and hospitalization of the mother. It should be noted that the usual dose of 1000 units of vitamin D is prescribed until the end of The pregnancy period will continue. Vitamin D consumption substance, its chemical composition is vitamin D3 (calciferol bag), mothers consume 1000 units of vitamin D3 for one week. And its manufacturing plant in Iran is the holder of the manufacturing license of Hakiman Teb Kar Company. Intervention 2: Control group: The usual dose of 1000 units of vitamin D per day will be prescribed until the end of pregnancy. 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 I haven't made a decision yet
public Somayeh Khajeh
Motahari 9, Plak 7
Birjand Iran (Islamic Republic of) 971966471 +98 915 562 4250 smyhkhwajh@gmail.com Gonabad University of Medical Sciences scientific Somayeh Khajeh
Motahari, Motahari 9 plate 7
Birjand Iran (Islamic Republic of) 9719664971 +98 915 562 4250 smyhkhwajh@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Vitamin D serum level less than 32 ng Willingness to participate in the study Age range 10-54 years Gestation age 24 to 36 weeks and 6 days Not having pregnancy complications based on the mother's statement or information in the mother's file (multiple twins, polyhydramnios, preeclampsia, uncontrolled diabetes, uncontrolled hypothyroidism) that causes premature birth. No rupture of the water bag Dilatation of less than 3 centimeters and defecation Failure to perform cerclage and history of cerclage Absence of urinary infection and vaginal infection during pregnancy based on the mother's statement or the information in the mother's file 10 years 56 years Female The mother's unwillingness to cooperate to take a blood sample Mother's unwillingness to continue studying Occurrence of intrauterine fetal death O60 Preterm labor Prevention N/A In the intervention group, an additional dose of 1000 units of vitamin D (2000 units in total) will be prescribed to the intervention group for a maximum of one week after the onset of premature labor symptoms and hospitalization of the mother. It should be noted that the usual dose of 1000 units of vitamin D is prescribed until the end of The pregnancy period will continue. Vitamin D consumption substance, its chemical composition is vitamin D3 (calciferol bag), mothers consume 1000 units of vitamin D3 for one week. And its manufacturing plant in Iran is the holder of the manufacturing license of Hakiman Teb Kar Company Control group: The usual dose of 1000 units of vitamin D per day will be prescribed until the end of pregnancy The number of people who gave birth prematurely (before 37 weeks of pregnancy). Timepoint: Before the intervention and one week after the intervention. Method of measurement: Follow-up of mothers and that their delivery was in several weeks of pregnancy. Gonabad University of Medical Sciences Approved 2024-01-07 کمیته اخلاق دانشگاه علوم پزشکی گناباد Motahari, Motahari 9 Birjand South Khorasan Iran (Islamic Republic of)