Protocol summary
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Study aim
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Evaluation of the effect of ante-natal betamethasone on the respiratory outcomes of late preterm labors (weeks 34 to 37)
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Design
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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.
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Settings and conduct
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Study place: Mahdieh hospital Tehran
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Treatment group: intramuscular injection of two 12 mg betamethasone doses apart 24 hours
Control group: delivery without betamethasone injection
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120918010876N3
Registration date:
2017-12-16, 1396/09/25
Registration timing:
registered_while_recruiting
Last update:
2018-01-03, 1396/10/13
Update count:
1
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Registration date
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2017-12-16, 1396/09/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2017-03-21, 1396/01/01
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Expected recruitment end date
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2018-02-20, 1396/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Assessment of efficacy of antenatal betamethasone on neonatal respiratory outcome of late preterm delivery (34-37 weeks) in singleton pregnancies
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Public title
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Assessment of efficacy of antenatal betamethasone on neonatal respiratory outcome of late preterm delivery (34-37 weeks)
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization with random number table
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-10, 1396/07/18
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Ethics committee reference number
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IR.sbmu.msp.rec.1396.458
Health conditions studied
1
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Description of health condition studied
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Respiratory distress syndrome of newborn
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ICD-10 code
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P22.0
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ICD-10 code description
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Respiratory distress syndrome of newborn
Primary outcomes
1
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Description
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Neonatal respiratory outcomes
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Timepoint
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After delivery until patient discharge
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Method of measurement
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Clinical symptoms & signs
2
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Description
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NICU admission
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Timepoint
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After delivery until patient discharge
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Method of measurement
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Clinical symptoms & signs
3
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Description
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Hospitalization duration
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Timepoint
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Patient discharge time
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Method of measurement
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Hospitalization duration in day and hour
Intervention groups
1
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Description
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Treatment group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours
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Category
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Treatment - Drugs
2
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Description
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Control group: No Treatment
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences- Mahdieh Hospital
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No need for publishing data file
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available