Protocol summary

Summary
The aim of this study is to investigate the efficacy of sublingual misoprostol to reduce blood loss in cesarean delivery. In this randomized control trail, 90 pregnant women who are at risk of post partum hemorrhage will be divided into two groups, first group will receive sublingual misoprostol (400 microgram) and oxytocin and the control group will receive oxytocin. Hemoglobin and need for additional uterotonic during operation will be compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041125648N3
Registration date: 2016-04-26, 1395/02/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Masoumeh Mirteimori
Name of organization / entity
Mashhad University of Medical Sciemces
Country
Iran (Islamic Republic of)
Phone
+98 915 113 0199
Email address
rahmanish3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-03-30, 1395/01/11
Expected recruitment end date
2016-05-01, 1395/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sublingual Misoprostol to Reduce Blood Loss in Cesarean Delivery
Public title
Sublingual Misoprostol to Reduce Blood Loss in Cesarean Delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: any of post partum hemorrhage risk factors in term pregnancies like uterine over distention (macrosomia or multiple pregnancies); arrested descent labor; prolonged induction. Exclusion criteria are: coagulopathies; anemia; adhesion bands,; organ damage during surgery (intestine; colon; Bladder; etc); allergy for prostaglandins, abnormal placenta; need for extended surgery incision and underlying diseases (diabetes mellitus; hypertension; ischemic heart disease; etc).
Age
No age limit
Gender
Female
Phase
N/A
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah Street, Mashhad University of Medical Sciences, Mashhad, Iran Mashhad
City
Mashhad
Postal code
1234567
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUMS.fm.REC.1394.354

Health conditions studied

1

Description of health condition studied
Cesarean Section
ICD-10 code
O82
ICD-10 code description
Single delivery by cesarean section

Primary outcomes

1

Description
Serum Hemoglobin
Timepoint
Before/ after surgery
Method of measurement
Laboratory

2

Description
Need for additional uterotonic usage
Timepoint
During surgery
Method of measurement
Clinical

Secondary outcomes

1

Description
Hospital stay duration
Timepoint
N/A
Method of measurement
Duration between admission and discharge

Intervention groups

1

Description
400 microgram Sublingual Misoprostol and oxytocin
Category
Treatment - Drugs

2

Description
Oxytocin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommol Banin Hospital
Full name of responsible person
Masoumeh Mirteimouri
Street address
Ayatollah Behjat Avenue, Ayatollah Behjat 16th, Mashhad, Iran
City
Mashhad

2

Recruitment center
Name of recruitment center
Ghaem Educational, Research and Treatment Center
Full name of responsible person
Masoumeh Mirteimouri
Street address
Ghaem Hospital, Dr. Shariati Square, beginning of Ahmadabad Avenue,
City
Mashhad

3

Recruitment center
Name of recruitment center
Imam Reza Educational, Research and Treatment Center
Full name of responsible person
Masoumeh Mirteimouri
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Qoreishi Building, Daneshgah Street, Vice Chancellor for Research of Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Mirteimouri
Position
Gynecologist/ Assistant professor
Other areas of specialty/work
Street address
Ayatollah Behjat Avenue, Ayatollah Behjat 16th, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3623 1061
Fax
Email
rahmanish3@mums.ac.irsh79316@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Mirteimouri
Position
Gynecologist/ Assistant professor
Other areas of specialty/work
Street address
Ayatollah Behjat Avenue, Ayatollah Behjat 16th, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3623 1061
Fax
Email
rahmanish3@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
Masoumeh Mirteimouri
Position
Gynecologist/ Assistant professor
Other areas of specialty/work
Street address
Ayatollah Behjat Avenue, Ayatollah Behjat 16th, Mashhad, Iran
City
Mashhad
Postal code
Phone
00
Fax
Email
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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