Objectives:
This study investigates the effect of Betamethasone on prevention of respiratory distress syndrome among neonates with gestational age of 34-36 weeks.
Design:
140 pregnant women aged between 18 to 39 years who are of high risk for preterm labor in 34-36 weeks will be randomly divided into control or intervention groups (each group contains 70 participants).
Setting and conduct:
The intervention group and control group will receive 2 doses of 3 ml of Betamethasone and normal saline (as the placebo), respectively.
Major Inclusion and Exclusion criteria:
Pregnant women who are candidate for delivery in 34-36th week of gestational age with the absence of underline diseases such as diabetes or special conditions like multiple pregnancy or fetal anomalies
Intervention:
Receiving Betamethasone or placebo (normal saline)
Main outcome measures (variables):
After delivery, data including apgar score, respiratory distress syndrome and other abnormalities of the newborns will be assessed and recorded in questionnaire by neonates specialist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102919037N2
Registration date:2014-11-10, 1393/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-10, 1393/08/19
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Betamethasone on Neonatal Outcomes in Late Preterm Pregnancies
Public title
Evaluation of the Effect of Betamethasone on Neonatal Outcomes in Pregnancies
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged between 18 to 39 years who are candidate for delivery in 34-36th week of gestational age
Exclusion criteria:
Delivery after 37th week of gestational age; diabetes; fetal anomalies; delivery before receiving the two doses of the drug; multiple pregnancy
Age
From 18 years old to 39 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Participants will be divided into two groups (control or intervention) by randomized block design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin university of medical sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
28.20.8737
Health conditions studied
1
Description of health condition studied
Respiratory Distress Syndrome of Newborn
ICD-10 code
P22.0
ICD-10 code description
Hyaline Membrane Disease
2
Description of health condition studied
Preterm Labour and Delivery
ICD-10 code
060
ICD-10 code description
Onset (Spontaneous) of Labour Before 37 Completed Weeks of Gestation
Primary outcomes
1
Description
Occurrence of respiratory distress syndrome of newborn
Timepoint
Every 30 min up to 48 h
Method of measurement
Questionnaire
2
Description
Apgar
Timepoint
At birth
Method of measurement
Checklist
Secondary outcomes
1
Description
Need for newborn admission
Timepoint
Up to 48 h
Method of measurement
Questionnaire
Intervention groups
1
Description
First intervention group:
Intramuscularly injection of 6ml of betamethasone solution (4mg/ml) (devided into two 3ml injection with a 12-hour interval), from Sahaamy-e Aam drug manufacturing company, Boroujerd, Iran, registered No. 1228030994
Category
Treatment - Drugs
2
Description
Second intervention group:
Intramuscularly injection of 6ml of normal saline solution (9mg/ml) (devided into two 3ml injection with a 12-hour interval), from Daroupakhsh drug manufacturing company, Tehran, Iran, registered No. 1228057458