Comparison of the effects of intramuscular methylergonovine, intravascular oxytocin, and sublingual prostaglandin (misoprostol) in active management of the third stage of labor
In this study, 150 pregnant women with singleton low risk pregnancies and live fetuses will enroll and randomly divided into three groups of 50 patients. The participants will observed until labor. After delivery of the anterior shoulder, the first group will given 400 µg of sublingual misoprostol; the second group, a 0.2 mg single dose of intramuscular methylergonovine, and the third group receive 20 units of intravascular oxytocin,(these drugs are given only one time). Three parameters will be measured and compared between these groups: the amount of hemorrhage during third and fourth stages of labor, the duration of the third stage of labor, and the degree of decrease in blood hemoglobin level 24 hours after delivery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106143756N2
Registration date:2011-09-20, 1390/06/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-20, 1390/06/29
Registrant information
Name
Tarlan Hamidehkhoo
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 2114
Email address
drnajafian.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University Of Medical Scienses
Expected recruitment start date
2010-11-21, 1389/08/30
Expected recruitment end date
2011-04-19, 1390/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of intramuscular methylergonovine, intravascular oxytocin, and sublingual prostaglandin (misoprostol) in active management of the third stage of labor
Public title
Comparison of the effects of intramuscular methylergonovine, intravascular oxytocin, and sublingual prostaglandin in prevention of post partum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women with singleton pregnancy; low risk pregnancies;live fetuses; cephalic presentation; normal blood pressure;no history of postpartum haemorrhage;no history of coagulation disorders;no history of heart disease;no history of seizure; no sever anemia(Hb less than 7)
exclusion criteria:
uterine atonia ;large lacerations with massive bleeding
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor For Research, Ahvaz University of Medical Scienses
Street address
Vice-Chancellor For Research, Ahvaz University of Medical Scienses ,golestan blvd,daneshgah square
City
Ahvaz
Postal code
Approval date
2010-11-06, 1389/08/15
Ethics committee reference number
ETH034
Health conditions studied
1
Description of health condition studied
Post partum haemorrhage
ICD-10 code
072.1
ICD-10 code description
Other immediate postpartum haemorrhage
Primary outcomes
1
Description
Volume of Postpartum haemorrhage
Timepoint
One hour after delivery
Method of measurement
Scaled container and scaling of the pad in mililiter
2
Description
Amount of hemoglobin drop
Timepoint
24 houres after delivery
Method of measurement
Check of hemoglobin
3
Description
Duration of the third phase of parturation
Timepoint
From fetus delivery to expression of placenta
Method of measurement
Check of the time in second
Secondary outcomes
1
Description
Nausia , vomitting, diarrhia and fever due to misoprostole
Timepoint
1 and 2 hour after delivery
Method of measurement
Patient's symptoms and vital siqns
2
Description
Hypotension and water intoxication
Timepoint
1 and 2 hour after delivery
Method of measurement
Patient's symptoms and vital siqns
3
Description
Transient hypertension due to metergin
Timepoint
1 and 2 hour after delivery
Method of measurement
Patient's symptoms and vital siqns
Intervention groups
1
Description
After delivery of anterior shoulder 0.2mg metergin IM,single dose
Category
Prevention
2
Description
After delivery of the anterior shoulder 20 unit oxytocin iv infusion,single dose
Category
Prevention
3
Description
After delivery of anterior shoulder 400 microgram misoprostole sublingual,single dose