Effectiveness of ACS in Extreme Preemies

NCT ID: NCT02351310

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2015-11-30

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)

Conditions

Preterm Labor; Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Betamethasone

Betamethasone: 12 mg given 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

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

Course of ACS given intramuscularly (2 doses of 12 mg, 24 hours apart)

Normal Saline

Quantity Sufficient (QS) of Normal Saline (NS) given intramuscularly (IM), 24 hours apart or if hospital is using Dexamethasone in place of Betamethasone then administer NS x 4 doses 12 hours apart

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: GENETIC

Course of placebo drug given intramuscularly (2 doses of normal saline (of equal quantity) 24 hours apart).

Interventions

Betamethasone

Course of ACS given intramuscularly (2 doses of 12 mg, 24 hours apart)

Intervention Type: DRUG

Placebo

Course of placebo drug given intramuscularly (2 doses of normal saline (of equal quantity) 24 hours apart).

Intervention Type: GENETIC

Other Intervention Names

ACS; Normal Saline

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

Exclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pediatrix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas J Garite, MD

Role: STUDY_DIRECTOR

Pediatrix

Other Identifiers

OBX0031

Identifier Type: -

Identifier Source: org_study_id