Clinical trial of the effects of misoprostol injection compared with oxytocin injection in the umbilical vein in treatment of placenta retaining after delivery
Objectives: Determine of the effect of misoprostol and oxytocin treatment of the placenta retaining
Designing : Women in labor room who have retained placenta divided into two groups randomly , single-blind, multicenter, Phase 3 of trial
Method: women who delivered vaginally in the third phase of labor more than 30 minutes with retained placenta divided into two groups randomly. First group take oxytocin injection (50 units) and second group take misoprostol injection( 800 mg). Both injections are done in umblical vein.
During the first and second stages of labor with success, leaving the pair within half an hour after leaving the fetus from the uterus, to obtain written consent from patients to participate in the study
Exclusion criteria:
Maternal and fetal problems that lead to vaginal delivery is possible. ; Placenta within half an hour after leaving the fetus from the uterus, patient request for exclusion
Intervention1: oxytocin 50 units in 30 mL of saline into the umbilical vein
Intervention 2: misoprostol injection of 800 mg in 30 mL of saline into the umbilical vein
Primary outcomes: the final withdrawal of uterus
Secondary outcomes: The Women treated postpartum bleeding and anemia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102824754N1
Registration date:2016-05-10, 1395/02/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-10, 1395/02/21
Registrant information
Name
Neda Hajiha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3615
Email address
nedahajiha94@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-09, 1395/02/20
Expected recruitment end date
2016-07-10, 1395/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effects of misoprostol injection compared with oxytocin injection in the umbilical vein in treatment of placenta retaining after delivery
Public title
The effect of misoprostol and oxytocin in the treatment of placenta retaining
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
During the first and second stages of labor with success, leaving the pair within half an hour after leaving the fetus from the uterus, to obtain written consent from patients to participate in the study
Exclusion criteria:
Maternal and fetal problems that lead to vaginal delivery is possible. ; Placenta within half an hour after leaving the fetus from the uterus, patient request for exclusion
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Moheb Yas hospital, North Villa St, Karim khan St.
City
Tehran
Postal code
Approval date
2016-05-08, 1395/02/19
Ethics committee reference number
IR.TUMS.REC.1395.2566
Health conditions studied
1
Description of health condition studied
Relation the effects of misoprostol and oxytocin in the treatment of placenta
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Withdrawal time of placenta
Timepoint
30 minutes
Method of measurement
According on minutes
Secondary outcomes
empty
Intervention groups
1
Description
Injection of oxytocin 50 units mixed with 30 mL of saline normal into the umbilical vein
Category
Treatment - Drugs
2
Description
Injection of misoprostol 800 mg mixed with 30 mL of saline normal into the umbilical vein
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Moheb Yas hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Deputy
Street address
BLW Keshavarz, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Neda Hajiha
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Moheb Yas hospital, North Villa St, Karim khan St.
City
Tehran
Postal code
Phone
+98 21 42460
Fax
Email
Neda_hajiha@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marziyeh Ghafarnejad
Position
Assistant Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Moheb Yas hospital, North Villa St, Karim khan St.
City
Tehran
Postal code
Phone
+98 21 42460
Fax
Email
ghafarin2@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Hajiha
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Moheb Yas hospital, North Villa St, Karim khan St.
City
Tehran
Postal code
Phone
+98 21 42460
Fax
Email
Neda_hajiha@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)