Clinical trial NCT02351310: Effectiveness of ACS in Extreme Preemies
Official title: Effects of Antenatal Corticosteroids in Patients With Early (22 - 23w6d) Threatened Preterm Birth
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Preterm Labor
Premature Birth
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of improving composite neonatal mortality and morbidity.

Detailed description: The purpose of this study to evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in patients who are threatening to deliver prematurely with well-established gestational ages between 22 0/7 and 23 6/7 weeks at the time of admission. If the delivery can be safely delayed at least 3 hours and there is no contraindication to steroid administration, the patient is eligible to be randomized. Randomization will be blinded to the patient and the staff caring for the patient and will be stratified by gestational age: those at 22 0/7 to 22 6/7 weeks and those at 23 0/7 weeks to 23 6/7 weeks. Randomized patients will be assignment to either active drug or placebo at the doses and frequencies below:

* 2 doses of Betamethasone, 12 mg intramuscularly (IM), 24 hours apart, or if as in some hospitals occasionally occurs and betamethasone is unavailable -
* 4 doses of Dexamethasone IM 6 mg, 12 hours apart.

Remainder of care will be at the discretion of the clinician.

Randomized 22 0/7 - 22 6/7:

For patients randomized between 22 0/7 and 22 6/7 weeks and who are undelivered \> 24 0/7 weeks, the decision as to whether to administer an additional course or courses of ACS will also be at the discretion of the clinician.

Randomized 23 0/7 to 23 6/7:

For those patients randomized at 23 0/7 to 23 6/7 weeks and who remain undelivered \> 24 0/7 weeks and \< 1 week after study medication was administered, a second blinded set of medications/placebos will be provided. For patients who received Betamethasone (or dexamethasone) placebo will be provided and for those who received placebo Betamethasone will be provided.(for both at the doses described in 3.4.3). In this group, at any time \> 24 0/7 weeks and less than one week of the previous dose, if the clinician feels the patient is still at risk for delivering, this second blinded set of study drugs will be administered. This will allow the patient to receive at least one actual course of ACS if undelivered at 24w0d. In this group, if the patient remains undelivered at \> 25 weeks, administration of an open label course of ACS will be at the discretion of the MD.

Primary Outcome of this study is composite morbidity and mortality. The N on this study is 68 (34 in each group)

Eligibility criteria: Inclusion Criteria:

* 18 years of age at time of study entry
* Gestational age between 22 0/7 to 23 6/7 weeks, inclusive at time of randomization regardless of whether the provider and patient decide to consider the fetus viable and provide obstetric interventions and cesarean section if needed.
* Singleton pregnancy
* Threatening to deliver by the best estimate of the clinician within the ensuing week
* Thought by the clinician to be able to delay delivery at least 3 hours from the time of randomization.
* Desired Pregnancy
* All clinical complications related to or leading to delivery except those listed as exclusion criteria are eligible. All of the following clinical complications are eligible including but not limited to:

  * premature labor,
  * incompetent cervix with or without prolapsing membranes,
  * Preterm Premature Rupture of the membranes (PPROM),
  * chorioamnionitis,
  * all hypertensive disorders of pregnancy,
  * vaginal bleeding due to placenta previa, abruption or unknown etiology,
  * being delivered for medical complication of pregnancy, and others.

Exclusion Criteria:

* Maternal history of insulin dependent diabetes
* Known congenital fetal anomaly
* Known Hydrops fetalis with this current pregnancy
* Severe intrauterine growth restriction \< 10% percentile
* Patient receiving corticosteroids for other maternal indications other than for fetal lung maturity
* Patient with h/o HIV or active Tuberculosis.
* Any other known contraindication to corticosteroids

Primary outcomes:
measure: Composite Neonatal Morbidity
timeFrame: First 30 days after birth
Secondary outcomes:
measure: Preterm Birth prior to 34weeks gestational age.
timeFrame: From entry into the study until 34 weeks gestational age.
measure: Respiratory Distress Syndrome (RDS)
timeFrame: First 30 days after birth
measure: Birth Weight
timeFrame: Measured at time of birth
measure: Newborn Head Circumference measurement
timeFrame: Measured at time of birth
measure: Need for Newborn Surfactant Therapy
timeFrame: First 30 days after birth
Other outcomes:
Locations:
Study officials:
affiliation: Pediatrix
name: Thomas J Garite, MD
role: STUDY_DIRECTOR
References: