Effect of Antenatal Corticosteroids on Neonatal Morbidity.

December 24, 2019 updated by: Anisah Yahya, Ahmadu Bello University Teaching Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Kaduna
      • Zaria, Kaduna, Nigeria, PMB 06
        • Ahmadu Bello University Teaching Hospital Shika-Zaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Respiratory distress syndrome
Time Frame: Within the first 72 hours of life
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:
Time Frame: Within the first 72 hours after delivery/birth
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.
Time Frame: Within the first 72 hours after delivery/birth
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.
Time Frame: Within the first 72 hours after delivery/birth
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Within the first 72 hours after delivery/birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmadu Bello University Teaching Hospital

Investigators

  • Principal Investigator: Anisah Yahya, MBBS, Ahmadu Bello University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 24, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AhmaduBUTH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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