Effect of Antenatal Corticosteroids on Neonatal Morbidity.
NCT ID: NCT03446937
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2017-12-01
2019-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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)
Dexamethasone Sodium Phosphate Injection
Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
Betamethasone sodium phosphate injection
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)
Betamethasone Sodium Phosphate Injection (Medication)
betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart
Water for injection
Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart.
Water for injection
Two doses of intramuscular injection of water for injection given 12 hours apart
Interventions
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Dexamethasone Sodium Phosphate Injection
Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
Betamethasone Sodium Phosphate Injection (Medication)
betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart
Water for injection
Two doses of intramuscular injection of water for injection given 12 hours apart
Other Intervention Names
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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 scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.
Exclusion Criteria
* Evidence of foetal distress.
* History of use of antenatal corticosteroids in index pregnancy.
* Women who do not give consent.
18 Years
49 Years
FEMALE
Yes
Sponsors
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Ahmadu Bello University Teaching Hospital
OTHER
Responsible Party
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Anisah Yahya
Lecturer I/Fellow
Principal Investigators
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Anisah Yahya, MBBS
Role: PRINCIPAL_INVESTIGATOR
Ahmadu Bello University
Locations
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Ahmadu Bello University Teaching Hospital Shika-Zaria
Zaria, Kaduna State, Nigeria
Countries
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References
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Yahya A, Sulayman HU, Abdulkadir I, Lawal BB. Effect of Antenatal Corticosteroids in Late Preterm Delivery on Neonatal Respiratory Morbidity: A Randomized Controlled Trial. Niger Med J. 2023 Oct 21;64(4):532-544. doi: 10.60787/NMJ-64-4-297. eCollection 2023 Jul-Aug.
Other Identifiers
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AhmaduBUTH
Identifier Type: -
Identifier Source: org_study_id