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. 2020 Dec 25;2020(12):CD004454. doi: 10.1002/14651858.CD004454.pub4

NCT03446937 2018.

Study name Effect of antenatal corticosteroids on neonatal morbidity
Methods Randomised parallel assignment three‐arm trial
Blinding: participant, care provider, investigator
Setting: Ahmadu Bello University Teaching Hospital Shika‐Zaria, Nigeria
Participants 100 participants
Inclusion criteria
  1. 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.

  2. 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
  1. Evidence of chorioamnionitis

  2. Evidence of fetal distress

  3. History of use of antenatal corticosteroids in index pregnancy

  4. Women who do not give consent

Interventions Group 1: dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
Group 2: betamethasone sodium phosphate injection12 mg X 2 doses given 12 hours apart
Group 3: placebo. two doses of intramuscular injection of water for injection given 12 hours apart
Outcomes Primary outcomes
  1. Neonatal Respiratory distress syndrome (Time Frame: within the first 72 hours of life)

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


Secondary outcomes
  1. Transient tachypnoea of the newborn within the first 72 hours after delivery/birth

  2. Admission into neonatal intensive care unit within the first 72 hours after delivery/birth

  3. Admission into neonatal intensive care unit. Apnoea. Within the first 72 hours after delivery/birth ]

Starting date Start date: December 2017
Completion date: May 2019
Contact information Anisah Yahya, MBBS, Ahmadu Bello University, Nigeria
moc.oohay@yhasina
Notes  

ACS: antenatal corticosteroids
NICU: neonatal intensive care unit