Induction of labor is one of the most common procedures during pregnancy. Various methods for cervical ripening and labor induction have been described, but the role of corticosteroids in the process of labor is not entirely understood. The aim of this study is to determine the effect of intramuscular dexamethasone on cervical ripening and induction of laborand its complications. This study was a double blinded, randomized clinical trial on 120 nulliparous women>=38weeks and bishop score>=7 with inclusion criteria (cephalic, singltone, membrane intact...) and exclusion criteria (vaginal bleeding, vaginal leakage, IUGR) admitted to the Ayatollah Ruhani hospital. Study group receives 8 mg (2cc) intramuscular dexamethasone phosphate 6 hours before induction. Induction starts after 6 hours for control group (n=60) following 2 cc distile water injection. Expect result was initiation of active phase of labor and duration of labor that is compare in both group. Data collection accomplishes by specific forms and data analysis does by spss-18 softwar.t test and chi-square test use for analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401221760N29
Registration date:2014-03-13, 1392/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-13, 1392/12/22
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2014-03-09, 1392/12/18
Expected recruitment end date
2014-06-08, 1393/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intramuscular administration of Dexamethasone on the induction of labor and duration of labor and its complications
Public title
Effect of intramuscular administration of Dexamethasone on the induction of labor and duration of labor and its complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with a gestational age of 38 weeks or more; Bishop score greater than or equal to 7; Singleton pregnancy, cephalic; Normal embryo sac.
Exclusion criteria: Abnormal vaginal bleeding (risk of placenta previa or placental abruption); History of any systemic diseases (HTN, DM, etc); Receiving any medical treatment except for routine supplementation in pregnancy; Suspected macrosomia (ultrasound or clinical assessment by a skilled person); Excessive uterine distension (polyhydroamnious evidence); presentation non-cephalic; Active phase of labor (cervical dilatation 2-3 cm4-3 with a strong contraction in width, 10); PROM; IUGR10; Fetal distress, bad hips; Any uterine abnormalities or any uterine surgery, including Cesarean delivery on admission;
Age
From 16 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
The Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Road
City
Babol
Postal code
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
3810/ژ/پ
Health conditions studied
1
Description of health condition studied
induction of labor
ICD-10 code
O60
ICD-10 code description
Preterm labour and delivery
2
Description of health condition studied
duration of labor
ICD-10 code
O60
ICD-10 code description
Preterm labour and delivery
Primary outcomes
1
Description
Reducing the time between the onset of the active phase of labor induction
Timepoint
6 hours after injection of dexamethasone and induction
Method of measurement
Clinical
2
Description
Reduce the duration of the active phase of labor
Timepoint
38 weeks to 42 weeks of gestation
Method of measurement
Clinical
3
Description
Reduction stage II of labor
Timepoint
Dilatation and expulsion of fetus
Method of measurement
Clinical
Secondary outcomes
1
Description
Apgar scores after birth
Timepoint
In the first minutes after birth
Method of measurement
Clinical
2
Description
Baby Weight
Timepoint
Birth
Method of measurement
Kg
Intervention groups
1
Description
Intervention groups:
dexamethasone sodium phosphate (2cc) (from Caspian) is injected. After 6 h induction begins.If you do not enter an active phase (3 contractions in 10 minutes with regular dilatation 3-4 cm) 6 h after induction with oxytocin infusion rate of 5/2 mm unit in minutes starts. This amount is increased to every 15 minutes.