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IRCT20221107056426N1 IRCT 2022-11-14 Gorgan University of Medical Sciences Efectiveness of dydrogesterone and progesterone in prevention of preterm birth in women with a short cervix Effectiveness of Dydrogesterone and Progesterone in prevention of preterm birth in women with a short cervix 2022-11-08 anticipated 64 Complete https://irct.ir/trial/66703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to randomize the samples, we use the block method with blocks of four. In this way, one of the following blocks is first chosen randomly (for example, with a dice) and according to the order of that, the samples are assigned to two groups. (A for the oral dydrogesterone group and B for the progesterone group (for example, if block three is selected and the first sample will be assigned to the group receiving dydrogesterone, the second and third samples will be assigned to the progesterone group, and the fourth sample will be assigned to the group receiving dydrogesterone. For the next four samples, we will randomly select a block again and perform the allocation according to it, and this process will continue until the end of the sampling, Blinding description: The blinding process is done in such a way that one group receives 3 oral pills of 10 mg of Dydrogesterone and a placebo vaginal suppository similar to vaginal progesterone, and the other group receives 3 oral placebo pills similar to Dydrogesterone in terms of size, color and shape, which is a complication for the mother and does not have a fetus, they are studied by uninformed people along with vaginal progesterone. 3 Preterm labour. Intervention 1: Intervention group: Vaginal progesterone group, daily one suppository of 400 mg of vaginal progesterone suppository and three oral pills of the same placebo (vitamin B6). Intervention 2: Control group: The oral dydrogesterone group will receive 30 mg of dydrogesterone tablets and a similar placebo suppository (vaginal glycerin suppository). Yes - There is a plan to make this available What will be shared: Information on the main outcome When: unlimited To whom: unlimited Conditions: unlimited Where to obtain: mahboobkhajepour@gmail.com Dr.mahboobeh khajehpour How to obtain: After viewing the message via email Comments:
public Mahboobeh Khajehpour
No 42, Alley 54, Shahid Mostafa Khomeini Street
Kerman Iran (Islamic Republic of) 7617657189 0098 43 32131722 Mahboobkhajepour@gmail.com Gorgan University of Medical Sciences scientific Mahboobeh Khajehpour
No42, Alley54, Shahid Mostafa Khomeini street
Kerman Iran (Islamic Republic of) 7617657189 0098 43 32131722 Mahboobkhajepour@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Cervical length less than 25 mm, measured by transvaginal ultrasound Singleton pregnancy Refer to the center at the age of pregnancy between 6 and 18 weeks Any evidence of threatened abortion( vaginal bleeding and bloody vaginal discharge) in the first half of pregnancy Willingness and written consent to enter the study Follow-up and regular referrals for pregnancy care no limit no limit Female Multiple pregnancy Any uncontrolled systemic disease(diabete, blood pressure, kidney, liver, etc.) History of consuming alcoholic beverages or drug or drug abuse Absence of gestational sac in the fifth week Lack of yolk sac in 5.5 to 6 weeks of pregnancy Absence of fetus in 6-6.5 weeks of pregnancy Absence of fetal heartbeat in weeks 16 to 24 Having a history of preterm delivery Having a pair of umbilical cords confirmed by transvaginal ultrasound History of surgery on the cervix Fetal and uterine anomalies O60 Preterm labor Prevention Prevention Intervention group: Vaginal progesterone group, daily one suppository of 400 mg of vaginal progesterone suppository and three oral pills of the same placebo (vitamin B6) Control group: The oral dydrogesterone group will receive 30 mg of dydrogesterone tablets and a similar placebo suppository (vaginal glycerin suppository). Cervical length. Timepoint: 1, 5, 9 weeks after starting treatment and immediately after delivery. Method of measurement: Vaginal ultrasound. Gorgan University of Medical Sciences Approved 2022-10-16 Ethics Committee of Gorgan University of Medical Sciences Central Organization of Golestan University of Medical Sciences and Healthcare ServicesŲŒ Hirkan Blvd, Gorgan Gorgan Golestan Iran (Islamic Republic of)