Comparison of three treatment methods in incisional pregnancy: methotrexate intrasac injection and potassium chloride intrasac injection and hysteroscopic resection
Comparison of three treatment methods in incisional pregnancy: methotrexate intrasac injection and potassium chloride intrasac injection under ultrasound guidance and hysteroscopic resection
Design
A randomized clinical trial with 3 parallel-groups, single-blind, design of 15 patients will be enrolled. The rand function of Excel software will be used for randomization.
Settings and conduct
This study is conducted in Al-Zahra level 3 referral Hospital in Tabriz, ,and all patients diagnosed with cesarean scar pregnancy and meeting the study criteria are included in the study.
Participants/Inclusion and exclusion criteria
IC:
Definitive diagnosis of incisional pregnancy
Stable hemodynamic status
Absence of severe vaginal bleeding
Consent to participate in the study
Pregnancy less than 10 weeks
EC:
History of drug sensitivity
History of blood disorders
Having liver disorders
Having pulmonary disorders
Intervention groups
Intervention group (IG) 1: injection, into the sac and if the heartbeat is seen, into the heart of the fetus, of methotrexate in the amount of 1.5 square centimeters from an ampoule of 50 mg per 2 square centimeters. These patients will undergo curettage the next day under transabdominal ultrasound.
(IG) 2: Intervention group: injection, into the sac and if the heartbeat is seen, into the heart of the fetus, of KCL in the amount of 1.5 square centimeters of a 15% solution. These patients will undergo curettage the next day under transabdominal ultrasound.
(IG) 3: After injecting 1 mg per square meter of intramuscular methotrexate, they will undergo hysteroscopic resection of cesarean scar pregnancy the next day.
Main outcome variables
The primary outcome of the study is the successful treatment of patients, which is characterized by the reduction of serum b-hCG levels until they become negative and the observation of an empty uterus by transvaginal ultrasound.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101227005485N10
Registration date:2023-01-06, 1401/10/16
Registration timing:prospective
Last update:2023-01-06, 1401/10/16
Update count:0
Registration date
2023-01-06, 1401/10/16
Registrant information
Name
Nazli Navali
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medecine
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 2879
Email address
navalin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three treatment methods in incisional pregnancy: methotrexate intrasac injection and potassium chloride intrasac injection and hysteroscopic resection
Public title
Comparison of three treatment methods in incisional pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of incisional pregnancy
Stable hemodynamic status
Absence of severe vaginal bleeding
Consent to participate in the study
Pregnancy less than 10 weeks
Exclusion criteria:
History of drug sensitivity
History of blood disorders
Having liver disorders
Having pulmonary disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants are unaware of the type of treatment they will receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research Deputy of Tabriz University of Medical Sciences, University of Tabriz, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-08-01, 1401/05/10
Ethics committee reference number
IR.TBZMED.REC.1401.422
Health conditions studied
1
Description of health condition studied
cesarean scar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary outcome of the study is the successful treatment of patients, which is the reduction of serum b-hCG levels until it become negative.
Timepoint
Every week
Method of measurement
Radioimmunoassay
2
Description
The primary outcome of the study is the successful treatment of patients, by confirming the empty uterus on the ultrasound exam.
Timepoint
Every mounth
Method of measurement
Transvaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: injection of methotrexate in the amount of 1.5 square centimeters from an ampoule of 50 mg per 2 square centimeters from Daro Derman Pars Company into the sac or if the heartbeat exist, into the heart of the fetus. These patients will undergo curettage the next day, under transabdominal ultrasound control.
Category
Treatment - Surgery
2
Description
Intervention group: injection of KCL in the amount of 1.5 square centimeters of 15% solution made by the Pasteur Institute (equivalent to 3 milliequivalents), into the sac or if the heartbeat exist, into the heart of the fetus. These patients will undergo curettage the next day under transabdominal ultrasound control.
Category
Treatment - Surgery
3
Description
Intervention group: After a day of injecting 1 mg per square meter of intramuscular methotrexate, they will undergo hysteroscopic resection of cesarean scar pregnancy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Navali Nazli
Street address
South Artesh
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr. Laya Farzadi
Street address
Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
infertility fellowship/associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Artesh
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
associate professor/infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Artesh
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalin@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
associate professor/infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Artesh
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3554 1221
Email
navalinph@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available