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Evaluation of the Effect of Betamethasone on Neonatal Outcomes in Pregnancies

Evaluation of the Effect of Betamethasone on Neonatal Outcomes in Late Preterm Pregnancies

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014102919037N2
Enrollment
140
Registered
2014-11-10
Start date
2013-11-22
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

Condition 1: Respiratory Distress Syndrome of Newborn. Condition 2: Preterm Labour and Delivery. Hyaline Membrane Disease Onset (Spontaneous) of Labour Before 37 Completed Weeks of Gestation

Interventions

Intervention 1: 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 manufact
Treatment - Drugs
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,
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, T

Sponsors

Investigator
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 39 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Occurrence of respiratory distress syndrome of newborn. Timepoint: Every 30 min up to 48 h. Method of measurement: Questionnaire.;Apgar. Timepoint: At birth. Method of measurement: Checklist.

Secondary

MeasureTime frame
Need for newborn admission. Timepoint: Up to 48 h. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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