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Impact of Betamethasone on preterm infants outcomes

Comparing the impact of one versus two doses of Betamethasone on preterm infants outcomes: A Clinical Trial Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014090912789N6
Enrollment
100
Registered
2014-10-20
Start date
2013-10-23
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. Hyaline membrane disease

Interventions

Intervention 1: In intervention group one dose of 12 mg Betamethasone 4 mg/ml from Abouraihan Pharmaceutical Company will be injected via intramuscular injection. Intervention 2: In control group two
Treatment - Drugs
In intervention group one dose of 12 mg Betamethasone 4 mg/ml from Abouraihan Pharmaceutical Company will be injected via intramuscular injection.
In control group two doses of 12 mg Betamethasone 4 mg/ml from Abouraihan Pharmaceutical Company with the interval of 24 hours will be injected via intramuscular injection.

Sponsors

Vice Chancellor for Research, Kurdistan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria were singleton pregnancy and gestational age 26- 34 weeks Exclusion criteria included: allergy to Betamethasone, history of any maternal systemic disorders like hypertension, diabetes, liver and cardiac disease, renal failure, neoplasia and cervical dilation > 5 cm.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Respiratory distress syndrome. Timepoint: Every day up to 28 days after birth. Method of measurement: sign and symptoms of Respiratory distress syndrome diagnosed by pediatrician.

Secondary

MeasureTime frame
Intraventricular Hemorrhage. Timepoint: Every day up to 28 days after birth. Method of measurement: Clinical examination by pediatrician.;Infant Death. Timepoint: Every day up to 28 days after birth. Method of measurement: Based on neonatologist diagnosis.;Necrotizing enterocolitis. Timepoint: Every day up to 28 days after birth. Method of measurement: Clinical examination by pediatrician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshte Seymari

Kurdistan University of Medical Sciences

seimaryf@gmail.com+98 87 3328 8119

Outcome results

None listed

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