Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Conditions
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Neonatal Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Dexamethasone Sodium Phosphate Injection
* Drug: Betamethasone Sodium Phosphate Injection (Medication)
* Drug: Water for injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone sodium phosphate injection<br>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) | Drug: Dexamethasone Sodium Phosphate Injection<br>* Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart<br>* Other names: Pemadex;|
| Experimental: Betamethasone sodium phosphate injection<br>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) | Drug: Betamethasone Sodium Phosphate Injection (Medication)<br>* betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart<br>|
| Placebo Comparator: Water for injection<br>Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart. | Drug: Water for injection<br>* Two doses of intramuscular injection of water for injection given 12 hours apart<br>* Other names: Juhel water for injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Respiratory distress syndrome | Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement. | Within the first 72 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transient tachypnoea of the newborn: | As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital | 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 | 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 | Within the first 72 hours after delivery/birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antenal corticosteroids, Late preterm delivery, Neonatal morbidity