This clinical trial aimed to evaluate the effect of intravenous dexamethasone in cervical ripening and induction of labor.
In a double-blind, randomized clinical trial, 172 women with first pregnancy and gestational age ≤ 40 weeks and Bishop Score ≤ 4 after written consent were enrolled and randomly divided into two groups. All patients with underlying diseases, diabetes, preeclampsia, breech presentation, twin pregnancy, macrosomia, induction of labor, spontaneous rupture of amniotic sac were excluded. Bishop Score of patients determined and they received Dexamethasone and distilled water as an intravenous injection every other. The interval between the labor inductions to onset of active phase were measured and recorded. Bishop score was determined again 4 hours after injection and both groups received oxytocin for induction of labor. The interval between the active phases to second stage of labor was also measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052613468N1
Registration date:2013-09-20, 1392/06/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Negin Mahboob Asiabar
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 6001
Email address
nmahboob@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of Dexamethasone effects in comparison with placebo on the ripening and Induction of labor in normal delivery.
Public title
Effects of intravenous Dexamethasone on labor induction.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All nulliparous women with gestational age>40 weeks; Bishop score≤ 4.
Exclusion criteria: Bishop score> 4; Diabetes; pre-eclampsia; maternal diseases; Bridge presentation; twin pregnancy; initiation of labor pain; Spontaneous rupture of the amniotic sac.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
172
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 Committee of Qazvin University of Medical Sicense
Street address
Qazvin University of Medical Sicense, Shahid Bahonar Boulvard
City
Qazvin
Postal code
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
28/20/7041
Health conditions studied
1
Description of health condition studied
Labour Induction with Dexamethasone
ICD-10 code
061.9
ICD-10 code description
Failure of Induction
Primary outcomes
1
Description
Ripening of cervix
Timepoint
In initiation of study
Method of measurement
Based on Boshop score
Secondary outcomes
1
Description
Neonetal APGAR
Timepoint
First and fifth minutes after delivery
Method of measurement
Standard method
Intervention groups
1
Description
After determining of Bishop score in case group 8 mg dexamthasone administrated by intravenous injection and 4 hours later Bishop score determined again and oxytocin administrated for labor induction.
Category
Treatment - Other
2
Description
After determining of Bishop score in control group2 cc water for injection (equal to dexamethasone volume) administrated by intravenous injection and 4 hours later Bishop score determined again and oxytocin administrated for labor induction.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Obestetric and Gynecology ward, Kowsar Hospital, Qazvin University of Medical Sciences
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Qazvin University of Medical Science
Full name of responsible person
Mr. Reza Ghadami
Street address
Shahid Bahonar Boulevard, Vice Chancellor for Research of Qazvin University of Medical Science
City
Qazvin
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 Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Negin Mahboob Asiabar
Position
Gynecology Resident
Other areas of specialty/work
Street address
Bahonar Boulvardو Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
nmahboob@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Negin Mahboob Asiabar
Position
Gynecology Resident
Other areas of specialty/work
Street address
Bahonar Boulvard, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
nmahboob@qums.ac.ir, neginmahboob@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Other areas of specialty/work
Street address
Kowsar Hospital, Basidj Bulvard
City
Semnan
Postal code
Phone
+98 23 1443 7846
Fax
Email
mehrdadzahmatkesh@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)