A Phase 2/3 interventional study of Betamethasone - ACTIVE and Normal Saline - PLACEBO in Premature Birth, sponsored by Pediatrix. Completed at 9 sites in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by Pediatrix · Phase 2/3, Interventional, and Treatment
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 194 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Booster Course of Antenatal Steroids consists of Betamethasone \[12 mg intramuscular injection, 24 hours apart X 2 doses\] or if unavailable may give Dexamethasone \[6 mg intramuscularly 12 hours apart x 4 doses\]
Drug: Betamethasone - ACTIVE
Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
Other: Normal Saline - PLACEBO
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
Also known as: antenatal corticosteroid, dexamethasone
normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
Also known as: NS
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.
Time frame: from birth through the first 28 days of life
Gestational age of baby
gestational age of the baby on the day of it's birth
Time frame: measured within the first 24 hours following birth.
Baby's birth weight
weight of the baby taken with in the first hours following birth
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: measured within the first 24 hours following birth
Newborn Hospital Days
the number of days that newborn remains in the hospital following its birth.
Time frame: measured within the first 24 hours following birth
Pneumothorax
diagnosis of a collapsed lung supported by clinical or radiologic evidence.
Time frame: measured within the first 24 hours following birth
Maternal Infectious Morbidity
diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.
Time frame: 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
Time frame: measured in days/hours from the time of administration of first study drug until birth.
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2016 to primary completion in Aug 2022, 77 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Pediatrix