Aim of study: Determine the effect of intramuscular dexamethasone on duration of labor in postdate pregnancy
Study Design: Randomized, single-blind, placebo-controlled study.
Inclusion and exclusion criteria: Inclusion criteria included 42-40 weeks gestational age, Bishop score less than or equal to 4. Exclusion criteria included premature rupture of membranes and hypertension .
Study population: 100 nulliparous women with Bishop Score less than 4 who referred to Ahvaz Amir Al Momenin hospital.
Intervention and its timing: March to October 2009. Single dose of intramuscular dexamethasone (8 mg) was administered to study group 12 h before induction. The controls were given 2 cc of normal saline at the same interval.
The primary outcome: the time between induction to bigining active phase is reduced.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042413109N1
Registration date:2013-09-22, 1392/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Leila Hajivandi
Name of organization / entity
Islamic Azad University of Kazerrun
Country
Iran (Islamic Republic of)
Phone
+98 917 721 2042
Email address
leilahajivandi@kau.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2009-04-06, 1388/01/17
Expected recruitment end date
2009-10-02, 1388/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Intramuscular Dexamethasone and Normal Saline On Duration of labor in Post Date Nulli Para Pregnancies
Public title
dexamethasone on prolonged pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bishop score less than or equal to 4; Cephalic presentation; Singleton gestations; Gestational age of 40 to 42 weeks
Exclusion criteria : Premature rupture of membrane; Diabetes mellitus and pre-eclampsia; Probable macrosomia
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
ahvaz medecine univercity
Street address
iran,ahvaz,bolvar golestan
City
ahvaz
Postal code
Approval date
2009-04-16, 1388/01/27
Ethics committee reference number
u88117
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
o48
ICD-10 code description
prolonged pregnancy
Primary outcomes
1
Description
duration of labor
Timepoint
evry 4 hours
Method of measurement
pelvic exam
Secondary outcomes
1
Description
cervical ripening
Timepoint
after 12 hours
Method of measurement
pelvic exam
Intervention groups
1
Description
in study group:dexamethasone group 8 mg (2 mL),
12 hours before initiation of labor induction; iran hormon
Category
Treatment - Drugs
2
Description
In the control group 2 mL normal saline 12 hours before initiation of labor induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Almomenin Hospital
Full name of responsible person
Leila Hajivandi
Street address
Town martyr Bahonar, Amir Almomenin Hospital, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Simin Montazeri
Street address
Golestan Blvd, Ahvaz University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Kazeron Islamic Azad University
Full name of responsible person
Leila Hajivandi
Position
1Nursing and Midwifery FacultY, Islamic Azad University Kazeron Branch