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Completed

NCT Number: NCT03446937

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.

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Key information

Conditions

Neonatal Respiratory Distress Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmadu Bello University Teaching Hospital Shika-Zaria

Zaria, Kaduna State, PMB 06, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone sodium phosphate injection

Drug

Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart

Other names: Pemadex

Betamethasone Sodium Phosphate Injection (Medication)

Drug

betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart

Water for injection

Drug

Two doses of intramuscular injection of water for injection given 12 hours apart

Other names: Juhel water for injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Ahmadu Bello University Teaching Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2018
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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