Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Betamethasone- ACTIVE · 1 trial · 1 indication
Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.
| Arm | Type | Description |
|---|---|---|
| Betamethasone - ACTIVE | EXPERIMENTAL | Booster Course of Antenatal Steroids consists of Betamethasone \[12 mg intramuscular injection, 24 hours apart X 2 doses\] or if unavailable may give Dexamethasone \[6 mg intramuscularly 12 hours apart x 4 doses\] |
| normal saline - PLACEBO | PLACEBO_COMPARATOR | Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm. |
| Name | Type | Description |
|---|---|---|
| Betamethasone - ACTIVE | DRUG | antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses. |
| Normal Saline - PLACEBO | OTHER | normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses |
Inclusion Criteria: * Participants age 18 years or older * 24w0d to 32w6d weeks gestation * Singleton pregnancy * Received first course of ACS at or prior to 31w6d gestation * Began first course of ACS at least 7 days ( =/\> 168 hours) prior to randomization * Expectant management planned * Prematu...
Betamethasone is a small molecule corticosteroid being studied for use in premature birth. It is given as a booster course of antenatal steroids to pregnant patients with premature rupture of the membranes, with the goal of improving neonatal outcomes. The drug is currently in Phase 2 clinical development.
Betamethasone is being developed by Pediatrix Medical Group, Inc., a company traded under the ticker MD. The company is conducting clinical research on the drug for the prevention of complications associated with premature birth.
Betamethasone is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its impact on neonatal outcomes in patients with premature rupture of the membranes.
Betamethasone has one completed clinical trial, NCT02469519, titled "Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes." This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 194 female participants aged 18 years and older in the United States.
Yes, Betamethasone is a corticosteroid, which is a type of small molecule. It is being studied as an antenatal steroid booster for pregnant women at risk of premature birth. The drug is administered to help improve outcomes for the neonate when premature rupture of the membranes occurs.