Women with ruptured ectopic pregnancy who are diagnosed by laparoscopy or laparotomy enrolled in the study will be randomly divided into two groups and for the first group, 20 units of oxytocin diluted in 20 ml had been injected and for the second group, 20 mL of normal saline was injected in Mesosalping under the ectopic pregnancy.
Three min after the injection, to Salpingostomy was done and trans operating bleeding, need to salpengoctomy due to the severity of bleeding, frequency use of coagulation and the rate of tubes to remain open were evaluated 2 months late.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304085283N5
Registration date:2013-06-24, 1392/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-24, 1392/04/03
Registrant information
Name
Manizheh Sayyah Melli
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3741
Email address
sayyahmellim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-05, 1392/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intramesosalpingeal of oxytocin for linear salpingostomy for salpingeal saving in unruptured ectopic pregnancy
Public title
Effect of Oxytocin on ectopic pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Less than 5 cm in size; Lack of Adherence on the tube; Safety of opposite side tube
Exclusion criteria: rapture ectopic pregnancy ; unstable hemodynamics
Age
From 10 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
gholghasht street
City
Tabriz
Postal code
Approval date
2012-04-04, 1391/01/16
Ethics committee reference number
91237
Health conditions studied
1
Description of health condition studied
Ectopic Pregnancy
ICD-10 code
O00.1
ICD-10 code description
Fallopian pregnancy
Primary outcomes
1
Description
Tube to remain open
Timepoint
2 months late
Method of measurement
hysterosalpingography
Secondary outcomes
empty
Intervention groups
1
Description
injection of Oxytocin in the Mesosalping in intervention group
Category
Treatment - Drugs
2
Description
injection of Normal salin in the Mesosalping in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
ِDr. sayyahmelli
Street address
Artesh Street , Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Women's Reproductive Health Research Center
Full name of responsible person
Dr Elaheh Olad Saheb Madarek
Street address
Al-Zahra
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
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
Manizheh Sayyahmelli
Position
Professor
Other areas of specialty/work
Street address
gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1337 3741
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Sayyahmelli
Position
Professor
Other areas of specialty/work
Street address
gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1337 3741
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Sayyahmelli
Position
Professor
Other areas of specialty/work
Street address
gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1337 3741
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)