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Comparison of Double and Single dose Methotrexate Protocols in the treatment of patients with tubal pregnancy

Protocol summary

Summary
This is a double-blind clinical trial to compare single and double doses methotrexate protocol for the treatment of ectopic pregnancy in Alzahra University Hospital. Inclusion criteria are: stable hemodynamic state; the initial β–hCG lower than 10000 mIU/ml; no fetal heart activity by transvaginal sonography and; the request of fertility preservation. exclusion criteria are: creatinine above 1.5 mg/dl; platelets count lower than 100000/ml and; increased liver enzymes. Patients which are candidates for medical therapy are randomly divided into two groups, single and double doses methotrexate protocols. In the first group, we will administer 50 mg/m2 methotrexate IM m on day 1, in the second group we will administer methotrexate on day 1 and 4, the serum day 4 and 7 β–hCG will be compared between the two groups. If there is a drop of 15%, the treatment is considered effective, if not the next doses of methotrexate are administered on day 7, and again on day 11. If there is not a drop of 15% of β–hCG on day 14, the patient will be operated. Before each methotrexate administration, CBC, liver ,and kidney laboratory tests will be done and the side effects like gastrointestinal symptoms, abdominal pain, epigastric pain, mucositis, hair loss will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610085485N6
Registration date: 2016-11-27, 1395/09/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-27, 1395/09/07
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
Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Double and Single dose Methotrexate Protocols in the treatment of patients with tubal pregnancy
Public title
Double and Single dose Methotrexate regimens in the treatment of ectopic pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: stable hemodynamic state; adnexal mass diameter lower than 4 cm; the initial β–hCG lower than 10000 mIU/ml; no fetal heart activity by transvaginal sonography and, the request of fertility preservation. exclusion criteria are: creatinine above 1.5 mg/dl; platelets count lower than 100000/ml; white blood cells count lower than 2000/ml and; increased liver enzymes.
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz University of Medical Sciences
Street address
Research Deputy of Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.TBZMED.REC.1395.597

Health conditions studied

1

Description of health condition studied
medical treatment of ectopic pregnancy
ICD-10 code
O00.1
ICD-10 code description
Tubal pregnancy Fallopian pregnancy

Primary outcomes

1

Description
beta-hCG decrease
Timepoint
days 7, 11 and,14
Method of measurement
blood exam

Secondary outcomes

1

Description
abdominal pain
Timepoint
daily and per patient report
Method of measurement
by visiting the patient and patient report

2

Description
drug side effects
Timepoint
days 4, 7 and, 11
Method of measurement
physical exam and blood tests

Intervention groups

1

Description
In the first group (single dose), we will administer 50 mg/m2 methotrexate IM on day 1, the serum day 4 and 7 β–hCG will be compared. If there is a drop of 15%, the treatment is considered effective, if not the next doses of methotrexate are administered on day 7,and again on day 11 if not effective with the same rule. If there is not a drop of 15% of β–hCG on day 14 in comparision to day 11, the drug therapy is failed and the patient will be operated.
Category
Treatment - Drugs

2

Description
In the second group (double dose), we will administer 50 mg/m2 methotrexate IM on day 1 and 4, the serum day 4 and 7 β–hCG will be compared. If there is a drop of 15%, the treatment is considered effective, if not the next doses of methotrexate are administered on day 7,and again on day 11 if not effective with the same rule. If there is not a drop of 15% of β–hCG on day 14 in comparision to day 11, the drug therapy is failed and the patient will be operated.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Nazli Navali
Street address
Artesh street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Medi
Full name of responsible person
Dr. Elahe Saheb Olad Madarec
Street address
Artesh street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Medi
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

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
Other areas of specialty/work
Street address
Artesh street, Alzahra Hospita, infertility department
City
Tabriz
Postal code
5138665793
Phone
+98 41 3554 1221
Fax
Email
navalin@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
infertility fellowship/associate professor
Other areas of specialty/work
Street address
Infertility department, Alzahra Hospital, Artesh street
City
Tabriz
Postal code
5138665793
Phone
+98 41 3554 1221
Fax
Email
navalin@tbzmed.ac.ir
Web page address

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
Other areas of specialty/work
Street address
Infertility department, Alzahra Hospital, Artesh street
City
Tabriz
Postal code
5138665793
Phone
+98 41 3330 9697
Fax
+98 35566449
Email
navalin@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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