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Trial record 54 of 272 for:    Betamethasone

Effect of Antenatal Corticosteroids in Late Preterm

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ClinicalTrials.gov Identifier: NCT01710384
Recruitment Status : Unknown
Verified October 2012 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
To test the effect on premature infants of a one-time course of betamethasone administered in weeks 34-36 of gestation.

Condition or disease Intervention/treatment Phase
Late Preterm Drug: betamethasone Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2012
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2015


Arm Intervention/treatment
Experimental: betamethasoneb, 34-36 weeks, preterm labor
betamethasone 12 mg 2 injections will be given 24-hours apart.
Drug: betamethasone
No Intervention: preterm labor, 34-37 weeks
betamethasone 12 mg 2 injections will be given 24-hours apart.



Primary Outcome Measures :
  1. neonate respiratory distress syndrome [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 1 and 5 minute Apgar scores, and complications during the first week of life, including hypoglycemia, seizures, intubation or medications [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to enhance fetal lung maturity during pregnancy 2. Clinical, sonographic or laboratory suspicion of premature labor 3. Singleton or twin pregnancy

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Exclusion Criteria:

  1. Premature rupture of membranes
  2. Fetus with known defects
  3. Suspicion of fetal distress
  4. Betamethasone administered during pregnancy for any reason

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01710384     History of Changes
Other Study ID Numbers: 006111
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: October 19, 2012
Last Verified: October 2012
Keywords provided by Meir Medical Center:
late preterm, betamethasone,
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents