This randomized clinical trial will be conducted in 1395 on 90 term pregnant women with risk factor for postpartum hemorrhage in Omolbanin hospital, Mashhad with spinal anesthesia. Patients will be assigned randomly (with random block method) in to two groups (intervention group: 30 unite intravenous oxytocin in 1000 cc ringer infusion [10ml/m] in 30 minutes and then 2 ml/min for next 6 hours plus 400 microgram sublingual misoprostol after cord clamping, control group: intervention group: 30 unite intravenous oxytocin in 1000 cc ringer infusion [10ml/m] in 30 minutes and then 2 ml/min for next 6 hours). Hemorrhage rate would be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030126857N1
Registration date:2017-01-18, 1395/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Roya Jalali
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3868 6050
Email address
jalalir921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sublingual misoprostol to reduce blood loss at cesarean delivery
Public title
Sublingual misoprostol to reduce blood loss at cesarean delivery
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: the term pregnant women with risk factor for post partum hemorrhage such as uterine overdistention (multifetal gestatation.macrosomia), arrest disorder, prolonged induction and prolonged preterm rupture of membrane
exclusion criteria: Lack of consent, coagulation disorders , Anemia, Intraabdominal adhesion, Intraoperative bladder and intestines and other viscera damage, Abnormal adhesion of placenta, extended Uterine incision during cesarean delivery and known hypersensitivity to misoprostol.
Age
No age limit
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be assigned randomly (with random block method) in to two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Administration Center(Qoreishi Building) – Daneshgah St. – Mashhad – Iran
City
Mashhad
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
IR.MUMS.fm.REC.1394.354
Health conditions studied
1
Description of health condition studied
postpartum hemorrhage
ICD-10 code
072
ICD-10 code description
Haemorrhage after delivery of fetus or infant
Primary outcomes
1
Description
Mean estimate blood loss
Timepoint
During surgery
Method of measurement
Milliliter
Secondary outcomes
1
Description
Adverse effect
Timepoint
In the first day after surgery
Method of measurement
presence or absence
Intervention groups
1
Description
intervention group: 30 unite intravenous oxytocin in 1000 cc ringer infusion [10ml/m] in 30 minutes and then 2 ml/min for next 6 hours plus 400 microgram sublingual misoprostol after cord clamping
Category
Treatment - Drugs
2
Description
control group: intervention group: 30 unite intravenous oxytocin in 1000 cc ringer infusion [10ml/m] in 30 minutes and then 2 ml/min for next 6 hours
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omolbanin hospital
Full name of responsible person
Dr. Roya Jalali
Street address
Mashhad University of Medical Sciences
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research of mashhad university of medical science
Full name of responsible person
Dr. Saied Eslami
Street address
Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research of mashhad university of medical science
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Roya Jalali
Position
Resident of obstetric and gynecology
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
iran
Phone
+98 51 3868 6050
Fax
Email
jalalir921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Maasoume Mirteimouri
Position
Assistant Professor
Other areas of specialty/work
Street address
omolbanin hospital
City
Mashhad
Postal code
Phone
+98 51 3802 2608
Fax
Email
mirteimourim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Roya Jalali
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
00
Fax
Email
jalalir921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)