Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Ahmadu Bello University Teaching Hospital

Status: Completed

Conditions: Neonatal Respiratory Distress Syndrome

Treatments: Drug: Water for injection; Drug: Betamethasone Sodium Phosphate Injection (Medication); Drug: Dexamethasone Sodium Phosphate Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03446937

AhmaduBUTH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Dexamethasone sodium phosphate injection

Experimental group

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)

Treatment:

Drug: Dexamethasone Sodium Phosphate Injection

Betamethasone sodium phosphate injection

Experimental group

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)

Treatment:

Drug: Betamethasone Sodium Phosphate Injection (Medication)

Water for injection

Placebo Comparator group

Description:

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

Treatment:

Drug: Water for injection