Comparison of single dose with multiple dose antenatal Betamethasone in pretrm infant's outcome

Single versus multiple courses of antenatal Betamethasone: evalualtion of preterm infant's outcome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138711261689N1

Enrollment

512

Registered

2009-05-16

Start date

2008-09-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory distress syndrome of newborn. Disorders related to short gestation and low birth weight, not elsewhere classified

Interventions

Intervention 1: A treatment course including an intramuscular injection of 12 mg Betamethasone repeated after 24 hours, followed by two courses of placebo every 10 days. Intervention 2: A treatment co

Treatment - Drugs

A treatment course including an intramuscular injection of 12 mg Betamethasone repeated after 24 hours, followed by two courses of placebo every 10 days.

A treatment course including an intramuscular injection of 12 mg Betamethasone repeated after 24 hours, followed by two other treatment courses every 10 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: High risk for preterm labor, gestational age between 28 weeks and 35 weeks and 6 days. Exclusion criteria: PROM prior to randomization, major fetal anomaly, chorioamnionitis, systemic corticostroid use during pregnancy, insulin dependent diabetes mellitus in mother.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Need to oxygen or CPAP. Timepoint: During hospital course. Method of measurement: Administration of oxygen and CPAP.;RDS. Timepoint: 28 days after birth. Method of measurement: Incidence of RDS.;Need to surfactant. Timepoint: Hospital course. Method of measurement: administration of surfactant during hospital course.;Need to mechanical ventilation. Timepoint: daily until 28 dayes after brith. Method of measurement: mechanical ventilation during hospital course.;Mortality. Timepoint: 28 dayes after brith. Method of measurement: Incidence of neonatal death.	—

Measure

Time frame

Need to oxygen or CPAP. Timepoint: During hospital course. Method of measurement: Administration of oxygen and CPAP.;RDS. Timepoint: 28 days after birth. Method of measurement: Incidence of RDS.;Need to surfactant. Timepoint: Hospital course. Method of measurement: administration of surfactant during hospital course.;Need to mechanical ventilation. Timepoint: daily until 28 dayes after brith. Method of measurement: mechanical ventilation during hospital course.;Mortality. Timepoint: 28 dayes after brith. Method of measurement: Incidence of neonatal death.

—

Secondary

Measure	Time frame
Infant's lenght. Timepoint: 72 hours after brith. Method of measurement: Centimeter.;Head circumference. Timepoint: 72 hours after brith. Method of measurement: centimeter.;Body weight. Timepoint: 72 hours after brith. Method of measurement: Balance in grams.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmotahare kheradmand

Mazandaran University of Medical Sciences and Helth services

elhamkheradmand2003@yahoo.comkheradmand@mazums.ac.ir+98 15132612458

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026