The surveya comparative study on the effect of Nitroglycerin and Misoprostol oncervical ripening before first-trimester curettage in women (aclinical trial)

comparative study oneffect of Nitroglycerin and Misoprostol on cervical ripeningbefore curettage in women for make easy the surgery and reduce the outcome.

This phase 3 double-blind clinical trial study is performed on 170 women candidates for curettage. First, people were selected gradually and 85 people were randomly selected by Sealed Envelope Ltd. online randomization service. 2019 will be in Group A and 85 people in Group B. Women in group A with a vaginal trinitroglycerin tablet of 400 micrograms, Women in group B receive misoprostol 400 micrograms vaginally according to the national protocol.

170 women referring to Al-Zahra Hospital will be enrolled during the year 1400. Women in group A will receive 400 micrograms trinitroglycerin vaginally by a female assistant, and women will receive 400 micrograms of misoprostol vaginally . 4 hours after, patients will be transferred for curettage. Rejection with a bogey of up to 8 mm indicates a response to the drug and if not rejected, be considered as a negative outcome.

Inclusion criteria include: un ripe cervix, complete satisfaction with the study, gestational age less than 14 weeks, normal vital signs, no drug use, no bleeding, coagulation disorders, active liver disease, cardiovascular disease, Uncontrolled seizures, history of glaucoma, adrenal disease, reason for termination of pregnancy (missed abortion, anembryonic pregnancy, medical abortion) not Inclusion criteria include: Patients who wish to have a medical abortion and are not candidates for curettage surgery. Women who have more than one history of uterine scarring.

Group A: 85 people will receive 400 mg of nitroglycerin vaginally. Group B 85 people will receive 400 mg of misoprostol vaginally

Cervical ripening

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

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.

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