Trial | NCT03446937  Report issue

Official Title

Effect of Antenatal Corticosteroids on Neonatal Morbidity.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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 Started
Dec 01
2017
Primary Completion
May 31
2019
Study Completion
May 31
2019
Last Update
Dec 27
2019

Drug Dexamethasone Sodium Phosphate Injection

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

  • Other names: Pemadex

Drug Betamethasone Sodium Phosphate Injection (Medication)

betamethasone sodium phosphate injection12mg X 2 doses 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

Dexamethasone sodium phosphate injection Experimental

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)

Betamethasone sodium phosphate injection Experimental

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)

Water for injection Placebo Comparator

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

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.
No Results Posted