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IRCT20190529043759N1 IRCT 2019-07-07 Zahedan University of Medical Sciences The Effect of Laminaria with Vaginal Misoprostol on Cervical Preparation in Induction of Second Trimester Abortion Comparison of the effect of vaginal misoprostol alone and vaginal misoprostol simultaneously with laminaria in induction of second trimester pregnancy (14-20 weeks) in patients referred to Imam Ali Hospital's Hospital (Clinical Practice) 2019-06-22 anticipated 90 Complete https://irct.ir/trial/40218 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Accidental assignment to intervention and control groups. To minimize the potential confounding effects, all participants with all the conditions for entry into the study will be randomized. Randomized blocked sampling will be based on gradual referral of eligible samples, Blinding description: Since the therapist is aware of the type of treatment and Laminaria and Misoprostol should be examined by the therapist for several hours, it is a blind side effect and patients are unaware of the treatment. We also use an assessment that does not know the treatment of the groups and we ask the evaluator for the statistics to get the statistics. 3 Medical abortion. Intervention 1: Intervention group: Embedding of Laminaria In the cervix with 400 μg Misoprostol Vaginally every 8 hours, up to 48 hours. Intervention 2: Control group: 400 μg Misoprostol Vaginally every 8 hours, up to 48 hours. 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 No more information
public Fatemeh Behnood
Persian Gulf Highway, Slamat Blvd., Ali Ibn Abi Talib Hospital
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3329 5570 dr.f.behnood@zaums.ac.ir Zahedan University of Medical Sciences scientific Fatemeh Behnood
Ali Ibn Abi Talib Hospital, Slamat Blvd., Persian Gulf Highway
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3329 5570 dr.f.behnood@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Pregnant women between 14-20 weeks of pregnancy at Imam Ali Hospital who are candidates for termination of pregnancy due to severe anomalies or due to fetal death Singleton conditions, parity 1 to 3, painless and uterine infections no limit no limit Female Allergy to the drug parity of more than three severe anemia active liver disease cardiovascular disease uncontrolled seizures having IUD Placenta Previa History of cesarean section previous incision on the uterus Use of corticosteroids Use of anti coagulants O04 Complications following (induced) termination of pregnancy Treatment - Drugs Treatment - Drugs Intervention group: Embedding of Laminaria In the cervix with 400 μg Misoprostol Vaginally every 8 hours, up to 48 hours Control group: 400 μg Misoprostol Vaginally every 8 hours, up to 48 hours Termination of pregnancy. Timepoint: Every eight hours to six times. Method of measurement: dilatation of cervix and contraction. Need for curettage. Timepoint: From the start, every eight hours to six turns. Method of measurement: Clinical examinations. Abortion time in labor. Timepoint: Interval between administration of drug and expulsion of fetus. Method of measurement: Record time. Time of admission in hospital after abortion. Timepoint: From the time of the abortion to the patient's discharge. Method of measurement: Record time. Zahedan University of Medical Sciences Approved 2018-05-15 Ethics Committee of Zahedan University of Medical Sciences Ali Ebn Abitaleb Hospital, Persian Gulf Expressway Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)