Effect of Antenatal Corticosteroids on Neonatal Morbidity.
- Conditions
- Neonatal Respiratory Distress Syndrome
- Interventions
- Registration Number
- NCT03446937
- Lead Sponsor
- Ahmadu Bello University Teaching Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- 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.
- Evidence of Chrioamnionitis.
- Evidence of foetal distress.
- History of use of antenatal corticosteroids in index pregnancy.
- Women who do not give consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone sodium phosphate injection Dexamethasone Sodium Phosphate Injection Intervention: Drug: Dexamethasone sodium phosphate injection Two doses Intramuscular Dexamethasone sodium phosphate 12mg given12 hours apart. (produced by Taizhou Overseas International Ltd. 126-128 Qingnian Road Jiaojiang, Taizhou, Zhejiang, China) Betamethasone sodium phosphate injection Betamethasone Sodium Phosphate Injection (Medication) Intervention: Drug: Betamethasone sodium phosphate injection Two doses of intramuscular betamethasone sodium phosphate 12mg given 12 hours apart. (obtained from Twinbrook pkwy, Rockville, MD Singapore. CAT No 1068004, Lot: R004e0) Water for injection Water for injection Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart.
- Primary Outcome Measures
Name Time Method Neonatal Respiratory distress syndrome Within the first 72 hours of life Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.
- Secondary Outcome Measures
Name Time Method Transient tachypnoea of the newborn: Within the first 72 hours after delivery/birth As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Admission into neonatal intensive care unit. Within the first 72 hours after delivery/birth As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
2. Admission into neonatal intensive care unit. Apnoea. Within the first 72 hours after delivery/birth As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Trial Locations
- Locations (1)
Ahmadu Bello University Teaching Hospital Shika-Zaria
🇳🇬Zaria, Kaduna, Nigeria