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IRCT20201111049352N1 IRCT 2020-12-06 Esfahan University of Medical Sciences The effect of laparoscopic salpingostomy, laparotomy, and methotrexate treatment on hysterosalpingography results Evaluation of the effect of treatment with laparoscopic salpingostomy, laparotomy and methotrexate treatment on the results of hysterosalpingography in patients with ectopic pregnancy 2019-03-21 anticipated 99 Complete https://irct.ir/trial/52283 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 99 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups. 2-3 Ectopic pregnancy. Intervention 1: Intervention group I: Patients in the first group undergo laparoscopic salpingostomy. So that, after the pneumoperitone is generated by the electronic pneumoperitoneum storz electronic device, an 11 mm trocar enters the abdomen from the umbilicus, then a laparoscope connected to the cold xenon light enters from the trocar and enters the outer end of the trocar attaches to the camera. After examining the abdomen and pelvis under direct vision, two 5.5 mm trocars are implanted in the lower abdomen to pass surgical instruments. First, the tube is determined and released, then a 1-2 cm incision is made in the antisentric section of the tube using a laser, micro electrode or scissors. The pregnancy product often protrudes spontaneously and gently comes out of the tube. Or is removed using hydrodissection and laparoscopic forceps. Intervention 2: Intervention group 2: Patients in the second group undergo laboratory surgery. So that, after opening the abdominal wall layers and exposing the uterus and cardiac tube, a 10-15 mm incision is made in the anticentric margin on the ectopic pregnancy. Pregnancy products usually come out of the incision site. Pregnancy products can be carefully removed or removed using a high-pressure washing system that removes the trophoblastic tissue more completely. Intervention 3: Intervention group 3: Patients in the third group, methotrexate at a dose of 50 mg/m2, will be given a single dose intramuscularly. 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 further information
public Behnaz Khani
Aria complex , Golshan deadend ,No. 2 alley ,baghziar st , esfahan city
Esfahan Iran (Islamic Republic of) 8781252633 +98 31 3779 0013 khani@mui.ac.ir Esfahan University of Medical Sciences scientific Mina Ahmadi
Department of Obstetrics & Gynecology, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 minaahmadi9026@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Mass diameter less than 3.5cm Stable hemodynamics Beat human chorionic gonadotrophin (BHCG) less than 5000 mIU/mL Satisfaction to participate in the study no limit no limit Female Ectopic pregnancy recurrence Fetal cardiac activity in ectopic pregnancy Having liver and kidney disease Having lung disease Having an active stomach ulcer Breastfeeding O.00 Ectopic pregnancy Treatment - Surgery Treatment - Surgery Treatment - Drugs Intervention group I: Patients in the first group undergo laparoscopic salpingostomy. So that, after the pneumoperitone is generated by the electronic pneumoperitoneum storz electronic device, an 11 mm trocar enters the abdomen from the umbilicus, then a laparoscope connected to the cold xenon light enters from the trocar and enters the outer end of the trocar attaches to the camera. After examining the abdomen and pelvis under direct vision, two 5.5 mm trocars are implanted in the lower abdomen to pass surgical instruments. First, the tube is determined and released, then a 1-2 cm incision is made in the antisentric section of the tube using a laser, micro electrode or scissors. The pregnancy product often protrudes spontaneously and gently comes out of the tube. Or is removed using hydrodissection and laparoscopic forceps. Intervention group 2: Patients in the second group undergo laboratory surgery. So that, after opening the abdominal wall layers and exposing the uterus and cardiac tube, a 10-15 mm incision is made in the anticentric margin on the ectopic pregnancy. Pregnancy products usually come out of the incision site. Pregnancy products can be carefully removed or removed using a high-pressure washing system that removes the trophoblastic tissue more completely. Intervention group 3: Patients in the third group, methotrexate at a dose of 50 mg/m2, will be given a single dose intramuscularly. Ectopic pregnancy mass siza. Timepoint: Three months after intervention. Method of measurement: Imaging. Infection. Timepoint: Three months after intervention. Method of measurement: Examination. Esfahan University of Medical Sciences Approved 2018-09-30 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq. Isfahan Isfehan Iran (Islamic Republic of)