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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03446937 |
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Date of registration:
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05/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Antenatal Corticosteroids on Neonatal Morbidity.
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Scientific title:
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Effect of Antenatal Corticosteroids on Neonatal Morbidity. |
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Date of first enrolment:
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December 1, 2017 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03446937 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Anisah Yahya, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ahmadu Bello University |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Neonatal Respiratory Distress Syndrome
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Intervention(s)
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Drug: Betamethasone Sodium Phosphate Injection (Medication)
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Drug: Dexamethasone Sodium Phosphate Injection
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Drug: Water for injection
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Primary Outcome(s)
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Neonatal Respiratory distress syndrome
[Time Frame: Within the first 72 hours of life]
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Secondary Outcome(s)
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Transient tachypnoea of the newborn:
[Time Frame: Within the first 72 hours after delivery/birth]
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Admission into neonatal intensive care unit.
[Time Frame: Within the first 72 hours after delivery/birth]
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2. Admission into neonatal intensive care unit. Apnoea.
[Time Frame: Within the first 72 hours after delivery/birth]
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Secondary ID(s)
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AhmaduBUTH
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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