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Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Primary Purpose

Neonatal Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Dexamethasone Sodium Phosphate Injection
Betamethasone Sodium Phosphate Injection (Medication)
Water for injection
Sponsored by
Ahmadu Bello University Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Respiratory Distress Syndrome focused on measuring Antenal corticosteroids, Late preterm delivery, Neonatal morbidity

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ahmadu Bello University Teaching Hospital Shika-Zaria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dexamethasone sodium phosphate injection

Betamethasone sodium phosphate injection

Water for injection

Arm Description

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)

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)

Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart.

Outcomes

Primary Outcome Measures

Neonatal Respiratory distress syndrome
Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.

Secondary Outcome Measures

Transient tachypnoea of the newborn:
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Admission into neonatal intensive care unit.
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
2. Admission into neonatal intensive care unit. Apnoea.
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital

Full Information

First Posted
February 5, 2018
Last Updated
December 24, 2019
Sponsor
Ahmadu Bello University Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03446937
Brief Title
Effect of Antenatal Corticosteroids on Neonatal Morbidity.
Official Title
Effect of Antenatal Corticosteroids on Neonatal Morbidity.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahmadu Bello University Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Distress Syndrome
Keywords
Antenal corticosteroids, Late preterm delivery, Neonatal morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone sodium phosphate injection
Arm Type
Experimental
Arm Description
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)
Arm Title
Betamethasone sodium phosphate injection
Arm Type
Experimental
Arm Description
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)
Arm Title
Water for injection
Arm Type
Placebo Comparator
Arm Description
Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Sodium Phosphate Injection
Other Intervention Name(s)
Pemadex
Intervention Description
Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
Intervention Type
Drug
Intervention Name(s)
Betamethasone Sodium Phosphate Injection (Medication)
Intervention Description
betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart
Intervention Type
Drug
Intervention Name(s)
Water for injection
Other Intervention Name(s)
Juhel water for injection
Intervention Description
Two doses of intramuscular injection of water for injection given 12 hours apart
Primary Outcome Measure Information:
Title
Neonatal Respiratory distress syndrome
Description
Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.
Time Frame
Within the first 72 hours of life
Secondary Outcome Measure Information:
Title
Transient tachypnoea of the newborn:
Description
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Time Frame
Within the first 72 hours after delivery/birth
Title
Admission into neonatal intensive care unit.
Description
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Time Frame
Within the first 72 hours after delivery/birth
Title
2. Admission into neonatal intensive care unit. Apnoea.
Description
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Time Frame
Within the first 72 hours after delivery/birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anisah Yahya, MBBS
Organizational Affiliation
Ahmadu Bello University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmadu Bello University Teaching Hospital Shika-Zaria
City
Zaria
State/Province
Kaduna
ZIP/Postal Code
PMB 06
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The outcome will be shared
IPD Sharing Time Frame
Data will be made available 6 months after completion and will be made available for 6 months
IPD Sharing Access Criteria
It will be shared on request

Learn more about this trial

Effect of Antenatal Corticosteroids on Neonatal Morbidity.

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