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IRCT20190208042655N2 IRCT 2022-03-16 Tehran University of Medical Sciences Comparison of successful abortion using misoprostol alone and misoprostol with vaginal estrogen Comparison of successful induced abortion using misoprostol alone and misoprostol with vaginal estrogen in women candidates for first and second trimester abortions 2022-04-30 anticipated 120 Complete https://irct.ir/trial/62469 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: First, 60 letters A and 60 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot. 3 The first and second trimester abortions. Intervention 1: Intervention group: In women candidates for abortion, misoprostol is prescribed according to FIGO criteria. In addition, half of a vaginal estrogen ointment is administered, an hour before misoprostol prescription. Then, vaginal estrogen is administered with misoprostol if needed up to a maximum of three doses. Intervention 2: Control group: In women candidates for abortion, misoprostol is prescribed according to FIGO criteria. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr. Saedi, and any analysis must be done with her opinion. Where to obtain: Dr. Nafiseh Saedi How to obtain: Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Nafiseh Saedi. Comments:
public Nafiseh Saedi
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8608 9089 nsaedi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Nafiseh Saedi
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8608 9089 nsaedi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Mother age more than 18 years Gestational age up to 28 weeks First gravidity First cesarean section repeat Body mass index between 25 to 35 kg/m2 Hemoglobin level more than 10 gr/dL 18 years no limit Female Scar in the uterine Leiomyoma in the uterine Blood coagulation disorder Previous attempts to induce abortion in the current pregnancy A medical disorder that prohibits abortion for example heart failure Allergy to misoprostol or estradiol Cervicitis and vaginitis Polyhydramnios The patient withdrawal to participate in the study O03 Spontaneous abortion Treatment - Drugs Treatment - Drugs Intervention group: In women candidates for abortion, misoprostol is prescribed according to FIGO criteria. In addition, half of a vaginal estrogen ointment is administered, an hour before misoprostol prescription. Then, vaginal estrogen is administered with misoprostol if needed up to a maximum of three doses. Control group: In women candidates for abortion, misoprostol is prescribed according to FIGO criteria. Successful abortion. Timepoint: Once, at the end of abortion. Method of measurement: Abortion product observation (placenta and fetus residual). Number of doses of misoprostol used. Timepoint: Once, at the end of abortion. Method of measurement: Counting misoprostol doses. Need to surgery. Timepoint: Once, at the end of abortion. Method of measurement: Curettage or hysterectomy conducting. Tehran University of Medical Sciences Approved 2022-02-06 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St Tehran Tehran Iran (Islamic Republic of)