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Effect of Antenatal Corticosteroids on Neonatal Morbidity.

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ClinicalTrials.gov Identifier: NCT03446937
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Anisah Yahya, Ahmadu Bello University Teaching Hospital

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.

Condition or disease Intervention/treatment Phase
Neonatal Respiratory Distress Syndrome Drug: Dexamethasone Sodium Phosphate Injection Drug: Betamethasone Sodium Phosphate Injection (Medication) Drug: Water for injection Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double blind
Primary Purpose: Prevention
Official Title: Effect of Antenatal Corticosteroids on Neonatal Morbidity.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 14, 2018


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 Name: 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 Name: Juhel water for injection




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446937


Contacts
Contact: Anisah Yahya, MBBS +2348035925175 anisahy@yahoo.com
Contact: Hajaratu S Umar, MBBS 08034505318 hajaratuumar@gmail.com

Locations
Nigeria
Ahmadu Bello University Teaching Hospital Shika-Zaria Recruiting
Zaria, Kaduna, Nigeria, PMB 06
Contact: Anisah Yahya, MBBS    08035925175    anisahy@yahoo.com   
Contact: Hajaratu Umar, MBBS    08034505318    hajaratuumar@gmail.com   
Sponsors and Collaborators
Ahmadu Bello University Teaching Hospital
Investigators
Principal Investigator: Anisah Yahya, MBBS Ahmadu Bello University

Responsible Party: Anisah Yahya, Lecturer I/Fellow, Ahmadu Bello University Teaching Hospital
ClinicalTrials.gov Identifier: NCT03446937     History of Changes
Other Study ID Numbers: AhmaduBUTH
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anisah Yahya, Ahmadu Bello University Teaching Hospital:
Antenal corticosteroids
Late preterm delivery
Neonatal morbidity

Additional relevant MeSH terms:
Infant, Premature, Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Newborn, Diseases
Dexamethasone acetate
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Dexamethasone
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors