Effect of Antenatal Corticosteroids on Neonatal Morbidity.

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: Neonatal Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Dexamethasone Sodium Phosphate Injection; Drug: Betamethasone Sodium Phosphate Injection (Medication); Drug: Water for injection

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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:	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.	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.	As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital	Within the first 72 hours after delivery/birth

Collaborators and Investigators

• Sponsor: Ahmadu Bello University Teaching Hospital
• Investigators: Principal Investigator: Anisah Yahya, MBBS, Ahmadu Bello University

Study record dates

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: Neonatal morbidity; Antenal corticosteroids; Late preterm delivery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anti-Asthmatic Agents; Respiratory System Agents; Dexamethasone; Dexamethasone acetate; BB 1101; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Dexamethasone 21-phosphate
• 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