Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02469519 | Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes | PHASE2 | COMPLETED | 194 | — | — | Mar 3, 2016 | Oct 31, 2022 | Dec 15, 2022 | 9 | United States |
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...