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IRCT20230814059146N1 IRCT 2023-08-22 DME of Nishtar hospital Effect of Vitamin D Supplement on Prevention of Preeclampsia in Pregnant Women PREV-D Comparing the Impact of Vitamin D Supplementation with Placebo on Pre-eclampsia Prevention in Pregnant Women 2022-01-19 anticipated 250 Complete https://irct.ir/trial/72107 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: stratfied simple random sampling technique, using random numbers first stratified by gender_, Blinding description: single blinding would involve ensuring that the participants (pregnant women) are unaware of whether they are receiving the actual Vitamin D supplementation or a placebo. This helps minimize bias and ensures that the results of the study are not influenced by the participants' or researchers' expectations or beliefs. 2-3 Pre-eclampsia: The occurrence of hypertension in pregnancy after 20 weeks of gestation. Intervention 1: Intervention group: In intervention group patients were given 50000 IU capsules of vitamin D3 once every 2 weeks. All patients were advised to take medicine (placebo or vitamin D) till 36 weeks of gestation. Preeclampsia was diagnosed on the basis of clinical examination (Blood pressure of140/90 mm Hg or higher) and laboratory investigation. (Protein urea +1). Blood pressure monitoring was done on every 15 days until the use of medicine. Intervention 2: Control group:. The control group was prescribed placebo in the form a another vitamin supplementation not containing vitamin D. All patients were advised to take medicine (placebo or vitamin D) till 36 weeks of gestation. Preeclampsia was diagnosed on the basis of clinical examination (Blood pressure of140/90 mm Hg or higher) and laboratory investigation. (Protein urea +1). Blood pressure monitoring was done on every 15 days until the use of medicine. No - There is not a plan to make this available Justification or reason for not sharing IPD is due to cultural reasons, patients usually hide personal data on individual basis
public Dr. Saima
Nishtar hospital, Multan
Multan Pakistan 66000 +92 311 8443876 saimashahzad35177@gmail.com DME, Nishtar hospital Multan scientific Saima Shahzad
Nishtar hospital, Multan
Multan Pakistan 66000 +92 300 7195857 saimashahzad35177@gmail.com Nishtar Medical University Pakistan Presented with prenatal care in outpatient department previous history of Preeclampsia gestational age of >20 weeks 18 years 40 years Female History of renal insufficiency History of cardiac disease History of hypertension before pregnancy lack of confidence in cooperation history of immunological disease patient willing to leave during trial 014 Pre-eclampsia Treatment - Drugs Placebo Intervention group: In intervention group patients were given 50000 IU capsules of vitamin D3 once every 2 weeks. All patients were advised to take medicine (placebo or vitamin D) till 36 weeks of gestation. Preeclampsia was diagnosed on the basis of clinical examination (Blood pressure of140/90 mm Hg or higher) and laboratory investigation. (Protein urea +1). Blood pressure monitoring was done on every 15 days until the use of medicine. Control group:. The control group was prescribed placebo in the form a another vitamin supplementation not containing vitamin D. All patients were advised to take medicine (placebo or vitamin D) till 36 weeks of gestation. Preeclampsia was diagnosed on the basis of clinical examination (Blood pressure of140/90 mm Hg or higher) and laboratory investigation. (Protein urea +1). Blood pressure monitoring was done on every 15 days until the use of medicine. Pre-eclampsia (Blood pressure measurement and proteinuria). Timepoint: From 20 weeks till 36 weeks of gestation, (every two weeks). Method of measurement: Blood pressure measurement using sphygmomanometer, and proteinuria by dipstick method. Type of delivery. Timepoint: At 40 weeks approximately. Method of measurement: Visual and medical record. Abortion rate. Timepoint: From 20 weeks till abortion. Method of measurement: Based on history and medical records. DME of Nishtar hospital Approved 2022-01-01 Institutional Ethical Review Board (IERB) Nishtar Hospital, Multan Multan Punjab Pakistan