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IRCT20210823052269N1 IRCT 2021-12-01 Arak University of Medical Sciences The effect of anti-inflammatory drug and acetaminophen on postpartum hypertension Comparison of the effect of nonsteroidal anti-inflammatory drugs and acetaminophen on postpartum hypertension in patients with preeclampsia 2021-11-06 anticipated 110 Complete https://irct.ir/trial/58450 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocking with the size of random blocks (2, 4, 6) and randomization will be done using random sequence generation software, which in addition to simple randomization is able to generate random sequences by blocking method. We also use random allocation concealment, which is the method used to execute a random sequence on study participants so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences, in this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed, Blinding description: Participants, principal investigator. The patient receives the drug (intervention or comparison group) in sealed packets that are coded. The coding is done by one of the project partners and the evaluator and the patient are blind. 2-3 Postpartum hypertension. Intervention 1: Intervention group 1: Mothers receiving acetaminophen 325 milligram suppository(Darupakhsh company) 24 hours after cesarean section every 6 hours until the end of hospitalization. Intervention 2: Intervention group 2: Mothers receiving 50 milligram diclofenac suppository(Darupakhsh company) 24 hours after cesarean section every 6 hours until the end of hospitalization. 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 "There is no more information."
public Mahsa Dargahian
Alam Al-Huda St., Shahid Shiroudi St.
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 86 3313 6055 mooniaclinic@gmail.com Arak University of Medical Sciences scientific Mahsa Dargahian
Alam Al-Huda St., Shahid Shiroudi St.
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 86 3313 6055 mooniaclinic@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Cesarean candidate patients No chronic liver, kidney, hemorrhagic disorders No history of allergy to nonsteroidal anti-inflammatory drugs and acetaminophen Severe preeclampsia or preeclampsia added to chronic hypertension with severe symptoms 18 years 35 years Female Increase in liver enzyme levels higher than 200 mg / dL Increase in serum creatinine higher than 2 mg / dL O15.2 Eclampsia in the puerperium Treatment - Drugs Treatment - Drugs Intervention group 1: Mothers receiving acetaminophen 325 milligram suppository(Darupakhsh company) 24 hours after cesarean section every 6 hours until the end of hospitalization Intervention group 2: Mothers receiving 50 milligram diclofenac suppository(Darupakhsh company) 24 hours after cesarean section every 6 hours until the end of hospitalization Primary variable: Duration of high blood pressure. Timepoint: Measure blood pressure for 24 hours every hour and then every 4 hours. Method of measurement: Mercury sphygmomanometer. Primary variable: Frequency of need to use short acting antihypertensive drugs. Timepoint: Measure blood pressure for 24 hours every hour and then every 4 hours. Method of measurement: Counting. Frequency of need to use short-acting antihypertensive drugs to control sudden hypertension in both groups receiving acetaminophen and nonsteroidal anti-inflammatory drugs. Timepoint: At the beginning of the study (before the intervention), for 24 hours every hour and then every 4 hours. Method of measurement: Counting. Arak University of Medical Sciences Approved 2021-04-21 Ethics committee of Arak University of Medical Sciences A'lam-Al-Hoda Street, Shahid Shiroodi Street Arak Markazi Iran (Islamic Republic of)