Objective: The effect of sequential administration of oxytocin and sublingual nitroglycerin for delivery of retained placenta.
Design: clinical trial.
Setting and conduct: double blind randomized.
Participants: Inclusion criteria : maternal age between 18- 40; gestational age of 26 completed weeks and more; singleton pregnancy; vaginal delivery and no placental delivery up to 30 minutes after neonatal birth despite of intramuscular oxitocine prescription and controlled cord traction .Exclusion criteria: any known systemic disorders; severe bleeding; known uterine malformations and suspicion for placenta accreta.
Intervention: In one group (40 women) two tablets of 0.5 milligram nitroglycerine (1 milligram in total) and in the other group (40 women) 2 tablets of placebo will be prescribed sublingual.
Main outcome: delivery of retained placenta.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405222624N16
Registration date:2014-06-22, 1393/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-22, 1393/04/01
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sequential administration of oxytocin and sublingual nitroglycerin for delivery of retained placenta.
Public title
Delivery of retained placenta .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : maternal age between 18- 40; gestational age of 26 completed weeks and more; singleton; vaginal delivery and no placental delivery up to 30 minutes after neonatal birth despite of intramuscular oxitocine prescription and controlled cord traction .
Exclusion criteria: any known systemic disorders; severe bleeding; known uterine malformations and suspicion for placenta accreta.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee of Iran University of Medical Sciences
Street address
Hemmat highway, Chamran Cross
City
Tehran
Postal code
Approval date
2014-04-29, 1393/02/09
Ethics committee reference number
93/د/105/ 493
Health conditions studied
1
Description of health condition studied
Retained placenta
ICD-10 code
O73.0
ICD-10 code description
Retained placenta without haemorrhage
2
Description of health condition studied
Retained placenta
ICD-10 code
O43.2
ICD-10 code description
Morbidly adherent placenta
3
Description of health condition studied
Retained placenta
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
delivery of retained placenta
Timepoint
5 minutes after prescription.
Method of measurement
Data sheets
Secondary outcomes
1
Description
amount of bleeding
Timepoint
the day after delivery
Method of measurement
hemoglobin concentration.
Intervention groups
1
Description
Intervention group: sublingual prescription of two 0.5 milligram tablets of nitroglycerin.
Category
Treatment - Drugs
2
Description
Control group: sublingual prescription of two tablets of placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Iran University of Medical Sciences.
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Hemmat High way, Chamran Cross.
City
Tehran
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 ,Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Other areas of specialty/work
Street address
Molavi Avenue, Molavi Cross.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)