Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Ahmadu Bello University Teaching Hospital150 enrolled

Overview

It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.

The study will be a double blind randomised controlled trial. There will be two study groups and one control group. The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate. The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate. The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

150

Conditions

Neonatal Respiratory Distress Syndrome

Interventions

Dexamethasone Sodium Phosphate InjectionDRUG

Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart

Betamethasone Sodium Phosphate Injection (Medication)DRUG

betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart

Water for injectionDRUG

Two doses of intramuscular injection of water for injection given 12 hours apart

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent. * Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent. Exclusion Criteria: * Evidence of Chrioamnionitis. * Evidence of foetal distress. * History of use of antenatal corticosteroids in index pregnancy. * Women who do not give consent.

Locations (1)

Ahmadu Bello University Teaching Hospital Shika-Zaria

Zaria, Kaduna State, Nigeria

Outcomes

Primary Outcomes

Neonatal Respiratory distress syndrome

Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.

Time frame: Within the first 72 hours of life

Secondary Outcomes

Transient tachypnoea of the newborn:

As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital

Time frame: Within the first 72 hours after delivery/birth

Admission into neonatal intensive care unit.

As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital

Time frame: Within the first 72 hours after delivery/birth

2. Admission into neonatal intensive care unit. Apnoea.

As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital

Time frame: Within the first 72 hours after delivery/birth

Data from ClinicalTrials.gov

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