Effectiveness of ACS in Extreme Preemies

NCT02351310 | Withdrawn Phase 3 DMC

• 1 other identifier: OBX0031
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Labor; Premature Birth

Outcome Measures

Primary Outcomes (1)

• Composite Neonatal Morbidity

  Defined as one or more of the following: fetal death, neonatal death within 30 days of delivery, respiratory distress syndrome (oxygen requirement, clinical diagnosis and consistent chest x-ray), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia, blood culture proven sepsis, necrotizing enterocolitis (NEC).

  First 30 days after birth

Secondary Outcomes (5)

• Preterm Birth prior to 34weeks gestational age.

  From entry into the study until 34 weeks gestational age.

• Respiratory Distress Syndrome (RDS)

  First 30 days after birth

• Birth Weight

  Measured at time of birth

• Newborn Head Circumference measurement

  Measured at time of birth

• Need for Newborn Surfactant Therapy

  First 30 days after birth

Study Arms (2)

Betamethasone

ACTIVE COMPARATOR

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

Drug: Betamethasone

Normal Saline

PLACEBO COMPARATOR

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

Genetic: Placebo

Interventions

Betamethasone DRUG

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

Also known as: ACS

Betamethasone

Placebo GENETIC

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

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatrix: lead

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Betamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Thomas J Garite, MD

  Pediatrix

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share