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IRCT20200608047685N3 IRCT 2022-04-30 Mashhad University of Medical Sciences Comparison of the effect of misoprostol alone and misoprostol with Foley catheter in termination of pregnancy in the second trimester Comparison of the effect of misoprostol and misoprostol with Foley cervical catheter for termination of pregnancy in women undergoing previous cesarean section in the second trimester of pregnancy 2022-01-05 anticipated 82 Complete https://irct.ir/trial/62880 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Excel software will be used to assign people to the control and intervention group. In this way, random codes prepared by Excel software are written as A / B codes on separate sheets. Each sheet is placed separately in an envelope so that the code inside it is not recognizable. With the referral of each eligible patient and after obtaining informed consent, an envelope is taken out and the patient is treated according to the code inside the envelope (code A for the control group and code B for the intervention group). N/A Disposal of vaginal products after previous cesarean section in the second trimester of pregnancy. Intervention 1: Intervention group: cases with fetus with FHR receive 200 micrograms of sublingual misoprostol every three hours (maximum 5 doses) until the onset of effective uterine contractions (at least 3 contractions in 10 minutes) or expulsion of pregnancy products and cases with IUFD receive half of this dose. If pregnancy products are not excreted within 24 hours of the intervention, the same protocol will be repeated for the patient. In addition to receiving sublingual misoprostol, the research units in this group will also receive Foley catheter number 16. Intervention 2: cases with fetus with FHR receive 200 micrograms of sublingual misoprostol every three hours (maximum 5 doses) until the onset of effective uterine contractions (at least 3 contractions in 10 minutes) or expulsion of pregnancy products and cases with IUFD receive half of this dose. If pregnancy products are not excreted within 24 hours of the intervention, the same protocol will be repeated for the patient. 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 Masoumeh Mirtaimouri
At the corner of Ayatollah Behjat .16, Zarrineh intersection
Mashhad Iran (Islamic Republic of) 1234567890 +98 915 310 6875 Mirtaimourim@mums.ac.ir Mashhad University of Medical Sciences scientific Masoumeh Mirteimori
At the corner of Ayatollah Behjat 16, Zarrineh Crossroads
Mashhad Iran (Islamic Republic of) 1234567890 +98 915 310 6875 Mirteimorim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) History of previous cesarean section Gestational age 15-28 weeks Intact membrane No vaginal bleeding Willingness to enter the study 18 years 45 years Female Allergy to prostaglandins Cervical Stenosis A history of more than three cesarean sections Treatment - Drugs Treatment - Drugs Intervention group: cases with fetus with FHR receive 200 micrograms of sublingual misoprostol every three hours (maximum 5 doses) until the onset of effective uterine contractions (at least 3 contractions in 10 minutes) or expulsion of pregnancy products and cases with IUFD receive half of this dose. If pregnancy products are not excreted within 24 hours of the intervention, the same protocol will be repeated for the patient. In addition to receiving sublingual misoprostol, the research units in this group will also receive Foley catheter number 16. cases with fetus with FHR receive 200 micrograms of sublingual misoprostol every three hours (maximum 5 doses) until the onset of effective uterine contractions (at least 3 contractions in 10 minutes) or expulsion of pregnancy products and cases with IUFD receive half of this dose. If pregnancy products are not excreted within 24 hours of the intervention, the same protocol will be repeated for the patient. Duration from the beginning of the intervention to vaginal delivery. Timepoint: During the intervention. Method of measurement: By the hour and with the help of vaginal examination by hand. Vaginal delivery in less than 24 hours. Timepoint: From the beginning of the intervention until 24 hours later. Method of measurement: Per hour and using a questionnaire. Number of doses of misoprostol. Timepoint: During the intervention. Method of measurement: Questionnaire. Mashhad University of Medical Sciences Approved 2021-12-28 Ethics committee of Mashhad University of Medical Sciences Ghoreishi building; Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)