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IRCT20210510051247N1 IRCT 2021-05-16 Rasht University of Medical Sciences Comparative study oneffect of Nitroglycerin and Misoprostol oncervical ripeningbefore curettage in women Nitroglycerin and Misoprostol oncervical ripening The surveya comparative study on the effect of Nitroglycerin and Misoprostol oncervical ripening before first-trimester curettage in women (aclinical trial) 2021-05-22 anticipated 170 Complete https://irct.ir/trial/56228 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible individuals will be divided into two groups A (nitroglycerin recipient) and B (Misoprostol recipient) using block randomization method with 4 and 6 block sizes. An online randomization service was used to generate the list. https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: After admitting patients to the hospital, first and second year residents examine and takenbiographies of women, if they are eligible to enter the study, based on the online randomization list available to the senior residents of a women's ward, a code is assigned to each patient. The basis of that code is in group A or B. Finally, 85 people in group A and 85 people in group B will be placed.In group A, receives 400 mg of trinitroglycerine equivalent to a gelatin capsule vaginally, and group B receives misoprostol 400 mg. The equivalent in group B200 mg tablets is given vaginally according to the national protocol. (Due to vaginal use and lithotomy positionwhile receiving the drug, it is not possible for the patient to see the drug. Because the medication is given to the patient by another person (first and second year resident), the researcher (evaluator) is unaware of the status of the groups. 4 hours after taking the drug dose (once), patients in both groups will be transferred to the operating room for curettage. Rejection with bogeyHegar up to 8 mm indicates the response to the drug and its success and without the need for Mechanical dilation will be performed. The second examination of patients is re-examined by a senior resident who is unaware of the treatment group. In operating room if bogeyHegar 8 mm is not passed through cervix, they will be considered as negative and unsuccessful results of the treatment method used and mechanical dilation performed before curettage. In whole stage of research the researcher is unaware of therapyin both groups. 3 Pregnancy ,Medical abortion, Nitroglycerin ., Misoprostol ,cervical ripening. Intervention 1: Intervention groups: Group A 85 people will receive 400 mg single dose of trinitroglycerin tablets of Dana Pharmaceutical Company vaginally. Intervention 2: Intervention group: Group B 85 people will receive 400 mg misoprostol tablets of Abu Reihan Pharmaceutical Company vaginally. 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 En There is still planning to share and publish
public Ghazaleh Ghorbani
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839- 41446 +98 13 3336 9224 gh.ghorbani7012@gmail.com Rasht University of Medical Sciences scientific Dr. fatemeh Hosseinzade
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839- 41446 +98 13 3336 9224 drfatemehhosseinzadeh@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) After obtaining full consent to participate in the study, pregnant women are candidates for curettage with a gestational age of less than 14 weeks who have a reason for termination of pregnancy (missed abortion, medical abortion) based on the case file documents And have normal vital signs including no fever( less than 38 ° C), normal heart rate between 70 and 100 and systolic blood pressure between 100 and 130. Also have a history of uterine scarring at most once, no drug abuse, no bleeding (based on initial examination )Lack of coagulation disorder or recent history of anticoagulants, no active liver disease, cardiovascular disease, uncontrolled seizures, history of glaucoma, adrenal insufficiency are the conditions for inclusion in the study. no limit no limit Female Patients who wish to have a medical abortion and are not candidates for curettage surgery for any reason. Women who have more than one history of uterine scarring are not included in the study XV004 XV Pregnancy, childbirth and the puerperium ,Medical abortion Treatment - Drugs Treatment - Drugs Intervention groups: Group A 85 people will receive 400 mg single dose of trinitroglycerin tablets of Dana Pharmaceutical Company vaginally. Intervention group: Group B 85 people will receive 400 mg misoprostol tablets of Abu Reihan Pharmaceutical Company vaginally Cervical ripening. Timepoint: Initial examination and 4 hours after receiving the drug. Method of measurement: Hegar Bogey No. 8 passes through the cervix. Requires mechanical dilatation. Timepoint: During curettage. Method of measurement: HegarBogey No. 8 passes through the cervix. Possible side effects (diarrhea, chills, abdominal pain, headache, hypotension and palpitations). Timepoint: Every 4 hours during hospitalization. Method of measurement: Questioning the patient, examination, control of vital signs. Rasht University of Medical Sciences Approved 2021-05-05 Ethics committee of Guilan University of Medical Sciences Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, ShahidSiadati St., Namjoo Ave., Rasht, Guilan, IRAN Rasht Guilan Iran (Islamic Republic of)