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This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone - ACTIVE | Drug | antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Neonatal Morbidity | 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. | from birth through the first 28 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age of baby | gestational age of the baby on the day of it's birth | measured within the first 24 hours following birth. |
| Baby's birth weight | weight of the baby taken with in the first hours following birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Porreco, MD | Pediatrix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | United States | ||
| Phoenix Perinatal Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36796641 | Derived | Porreco R, Garite TJ, Combs CA, Maurel K, Huls CK, Baker S, Fortner KB, Longo SA, Nageotte M, Lewis D, Tran L; Obstetrix Collaborative Research Network. Booster course of antenatal corticosteroids after preterm prelabor rupture of membranes: a double-blind randomized trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100896. doi: 10.1016/j.ajogmf.2023.100896. Epub 2023 Feb 14. |
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| 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 |
|
|
| measured within the first 24 hours following birth |
| Intrauterine growth restriction (IUGR) | a measurement done by ultrasound taken at any time during the pregnancy prior to birth | anytime during the pregnancy prior to birth (~ 9 months of pregnancy) |
| Baby's Head Circumference | a measurement of the baby's head taken within the first hours following birth | measured within the first 24 hours following birth |
| Newborn Mechanical Ventilatory days | measurement of the total number of days the baby requires mechanical ventilatory support | measured from birth to 28 days following birth |
| Newborn Oxygen support days | measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP) | measured from birth to 28 days following birth |
| Newborn Surfactant therapy | measurement of the need for newborn surfactant therapy within the first 28 day following birth | measured within the first 24 hours following birth |
| Newborn Hospital Days | the number of days that newborn remains in the hospital following its birth. | measured within the first 24 hours following birth |
| Pneumothorax | diagnosis of a collapsed lung supported by clinical or radiologic evidence. | measured within the first 24 hours following birth |
| Maternal Infectious Morbidity | diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection. | measured within the first 24 hours following birth |
| time from first dose of study drug to birth | the number of hours/days from the time of the first dose of study drug until birth | measured in days/hours from the time of administration of first study drug until birth. |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90801-1428 | United States |
| Good Samaritan Hospital | San Jose | California | 95008 | United States |
| Presbyterian/St Luke's Hospital | Denver | Colorado | 80218 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Lousiana State University Health Science | Shreveport | Louisiana | 60612 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Swedish Medical Center | Seattle | Washington | 98122-4307 | United States |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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