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IRCT20191104045328N14 IRCT 2022-12-26 Arak University of Medical Sciences The effect of metformin on reducing preeclampsia The effect of metformin on the incidence of preeclampsia in pregnant women with low pregnancy-associated plasma protein A 2023-01-10 anticipated 80 Complete https://irct.ir/trial/67435 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced, Blinding description: This trial is single-blind. For this purpose, one group will receive metformin tablets and the other group will receive a starch tablet similar to metformin, and the mothers participating in the study are not aware of the type of drug. 3 Pre-eclampsia. Intervention 1: Intervention group: Patients in this group will receive metformin 500 mg oral tablets of Exir pharmaceutical company once a day until the end of pregnancy. Intervention 2: Control group: Patients in this group will receive an oral tablet similar to metformin made of starch daily until the end of pregnancy. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2023/4/20 to 2026/4/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: University researchers and university professors, after contacting the respective professor by message or email, can request the utilization and use of data from Dr. Maryam Maktabi and then Dr. Seyedeh Arzoo Afzal Shahidi, respectively. Dr. Maryam Maktabi: Phone: 09121951402 Email: Dr.maryam.maktabi@gmail.com Address: Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran Dr. Seyedeh Arzoo Afzal Shahidi: Phone: 09153221459 Email: 15.a.shahidi@gmail.com Address: Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Maryam Maktabi
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 Dr.maryam.maktabi@gmail.com Arak University of Medical Sciences scientific Dr. Azam Muslimi
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3222 2003 Azammoslemi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers with low pregnancy-related plasma protein A referred to kousar Clinic Normal arterial Doppler ultrasound Age 18-50 years Consent to participate in the study 15 years 50 years Female History of intrauterine growth restriction or preeclampsia, gestational hypertension or pregnancy complications in previous pregnancies History of congenital disease History of liver or kidney failure O14 Pre-eclampsia Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group will receive metformin 500 mg oral tablets of Exir pharmaceutical company once a day until the end of pregnancy. Control group: Patients in this group will receive an oral tablet similar to metformin made of starch daily until the end of pregnancy. Functional liver enzymes. Timepoint: in the 14th, 28th, 32nd weeks of pregnancy and at the time of delivery. Method of measurement: laboratory test. Systolic and diastolic blood pressure. Timepoint: in the 14th, 28th, 32nd weeks of pregnancy and at the time of delivery. Method of measurement: Mercury sphygmomanometer. Proteinuria. Timepoint: in the 14th, 28th, 32nd weeks of pregnancy and at the time of delivery. Method of measurement: Urinalysis test. Preterm delivery. Timepoint: Delivery between 20 and 37 weeks. Method of measurement: Delivery. Low birth weight. Timepoint: Birth weight less than 2500 grams. Method of measurement: scales. Type of delivery. Timepoint: How the baby is born. Method of measurement: Cesarean-vaginal. Arak University of Medical Sciences Approved 2022-06-13 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)