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Evaluation of the effect of treatment with laparoscopic salpingostomy, laparotomy and methotrexate treatment on the results of hysterosalpingography in patients with ectopic pregnancy

Protocol summary

Study aim
The effect of laparoscopic salpingostomy, laparotomy, and methotrexate treatment on hysterosalpingography results
Design
A randomized clinical trial with the parallel groups, without blinding
Settings and conduct
In this study, 99 patients with ectopic pregnancy will be included in the study and will be randomly divided into three groups. These patients will be treated with laparoscopic salpingostomy, laparotomy and methotrexate treatment, respectively. They undergo hysterosalpingography three months after the intervention. Ectopic pregnancy mass size and infection will then be assessed and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria include mass diameter less than 3.5 cm, stable hemodynamics, Beat human chorionic gonadotrophin (BHCG) less than 5000 mIU/mL, and satisfaction to participate in the study. Exclusion criteria include ectopic pregnancy recurrence, fetal cardiac activity in ectopic pregnancy, having liver and kidney disease, having lung disease, having an active stomach ulcer, and breastfeeding.
Intervention groups
Intervention group 1: Patients in this group are treated with laparoscopic salpingostomy. Intervention group 2: Patients in this group undergo laparotomy. Intervention group 3: Patients in this group will be treated with methotrexate. All patients undergo hysterosalpingography three months after the intervention. It was done three months after the intervention, 2-5 days after onset of the menstrual period, but before the ovulation period, so that it was ensured about the subjects were not pregnant.
Main outcome variables
Ectopic pregnancy mass size; infection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201111049352N1
Registration date: 2020-12-06, 1399/09/16
Registration timing: retrospective

Last update: 2020-12-06, 1399/09/16
Update count: 0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Mina Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3779 0013
Email address
masoudAhmadi2423@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2020-07-19, 1399/04/29
Trial completion date
2020-07-19, 1399/04/29
Scientific title
Evaluation of the effect of treatment with laparoscopic salpingostomy, laparotomy and methotrexate treatment on the results of hysterosalpingography in patients with ectopic pregnancy
Public title
The effect of laparoscopic salpingostomy, laparotomy, and methotrexate treatment on hysterosalpingography results
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mass diameter less than 3.5cm Stable hemodynamics Beat human chorionic gonadotrophin (BHCG) less than 5000 mIU/mL Satisfaction to participate in the study
Exclusion criteria:
Ectopic pregnancy recurrence Fetal cardiac activity in ectopic pregnancy Having liver and kidney disease Having lung disease Having an active stomach ulcer Breastfeeding
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 99
Actual sample size reached: 99
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.MUI.MED.REC.1398.268

Health conditions studied

1

Description of health condition studied
Ectopic pregnancy
ICD-10 code
O.00
ICD-10 code description
Ectopic pregnancy

Primary outcomes

1

Description
Ectopic pregnancy mass siza
Timepoint
Three months after intervention
Method of measurement
Imaging

2

Description
Infection
Timepoint
Three months after intervention
Method of measurement
Examination

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Surgery

2

Description
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.
Category
Treatment - Surgery

3

Description
Intervention group 3: Patients in the third group, methotrexate at a dose of 50 mg/m2, will be given a single dose intramuscularly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahran Hospital
Full name of responsible person
Mina Ahmadi
Street address
Soffe Blvd., Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
minaahmadi9026@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behnaz Khani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Aria complex , Golshan deadend ,No. 2 alley ,baghziar st , esfahan city
City
Esfahan
Province
Isfehan
Postal code
8781252633
Phone
+98 31 3779 0013
Fax
Email
khani@mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Ahmadi
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics & Gynecology, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
minaahmadi9026@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Ahmadi
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics & Gynecology, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
minaahmadi9026@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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