Evaluation of the effect of ante-natal betamethasone on the respiratory outcomes of late preterm labors (weeks 34 to 37)
Design
Women with singleton pregnancy at 34 weeks and 0 days to 36 weeks and 6 days and high probability of preterm labor (in weeks 37-34) will enroll in the study. Exclusion criteria include no exact gestational age, cervix dilatation of 4 cm or more, planned delivery after 36 weeks and 6 days, known congenital malformations, received corticosteroids before week 34 or for other indications, fetal death, major fetal anomaly, non-viable fetus, gestational diabetes, diabetes before pregnancy, maternal contraindications for betamethasone, and chorioamnionitis. Patients were randomly assigned into either group of treatment (intramuscular injection of two 12 mg betamethasone doses apart 24 hours) or in the control group according to the random numbers table. Then the women are routinely taken care of. After birth, neonatal data and respiratory outcomes are recorded, too.
Settings and conduct
Study place: Mahdieh hospital Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with singleton pregnancy at 34 weeks and 0 days to 36 weeks and 6 days and high probability of preterm labor (in weeks 37-34) will enroll in the study.
Exclusion criteria: No exact gestational age, cervix dilatation of 4 cm or more, planned delivery after 36 weeks and 6 days, known congenital malformations, received corticosteroids before week 34 or for other indications, fetal death, major fetal anomaly, non-viable fetus, gestational diabetes, diabetes before pregnancy, maternal contraindications for betamethasone, and chorioamnionitis.
Intervention groups
Treatment group: intramuscular injection of two 12 mg betamethasone doses apart 24 hours
Control group: delivery without betamethasone injection
Main outcome variables
Neonatal respiratory outcomes (need for CPAP or nasal cannula with high-current continuous, need for continuous high-pressure oxygen with FiO2 more than 30%, need for mechanical ventilation, need for ECMO or resuscitation at birth, respiratory distress syndrome, neonatal tachypnea, apnea, bronchopulmonary dysplasia, pneumonia, use of surfactant), the need for care in the NICU, and the duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120918010876N3
Registration date:2017-12-16, 1396/09/25
Registration timing:registered_while_recruiting
Last update:2017-12-16, 1396/09/25
Update count:1
Registration date
2017-12-16, 1396/09/25
Registrant information
Name
Masumeh Mirza Moradi
Name of organization / entity
Prinatalogy department of Mahdieh hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 6263
Email address
m-bakhtiyari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of efficacy of antenatal betamethasone on neonatal respiratory outcome of late preterm delivery (34-37 weeks) in singleton pregnancies
Public title
Assessment of efficacy of antenatal betamethasone on neonatal respiratory outcome of late preterm delivery (34-37 weeks)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy
Gestational age from 34 weeks and 0 days to 36 weeks and 6 days
High probability of preterm labor (in weeks 37-34) due to premature rupture of membranes
Preterm labor with intact membranes
preterm labor with any indication (including previous cesarean section, intrauterine growth retardation (IUGR), Oligohydramnios, pre-eclampsia, etc.)
Exclusion criteria:
No exact gestational age (unknown firt day of last menstrual period (LMP) or no ultrasound dating)
Cervix dilatation of 4 cm or more
Planned delivery after 36 weeks and 6 days
Known congenital malformations
Received corticosteroids before week 34 or for other indications
Fetal death
Major fetal anomaly
Non-viable fetus
Gestational diabetes
Diabetes before pregnancy
Maternal contraindications for betamethasone
Chorioamnionitis
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
IR.sbmu.msp.rec.1396.458
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Neonatal respiratory outcomes
Timepoint
After delivery until patient discharge
Method of measurement
Clinical symptoms & signs
2
Description
NICU admission
Timepoint
After delivery until patient discharge
Method of measurement
Clinical symptoms & signs
3
Description
Hospitalization duration
Timepoint
Patient discharge time
Method of measurement
Hospitalization duration in day and hour
Secondary outcomes
empty
Intervention groups
1
Description
Treatment group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours
Category
Treatment - Drugs
2
Description
Control group: No Treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh-haspital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh-haspital@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
Full name of responsible person
Dr Fatemeh Hasaninejad
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
z.joshaghani@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available