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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03446937
Other study ID # AhmaduBUTH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date May 31, 2019

Study information

Verified date December 2019
Source Ahmadu Bello University Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 150
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Hyaline Membrane Disease
  • Neonatal Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

Intervention

Drug:
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

Locations

Country Name City State
Nigeria Ahmadu Bello University Teaching Hospital Shika-Zaria Zaria Kaduna

Sponsors (1)

Lead Sponsor Collaborator
Ahmadu Bello University Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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