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Sponsored by: |
MemorialCare |
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Information provided by: | MemorialCare |
ClinicalTrials.gov Identifier: | NCT00641784 |
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
Condition | Intervention | Phase |
---|---|---|
Obstetric Labor, Premature |
Drug: Magnesium Drug: Nifedlipine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin |
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Oral Nifedine
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Drug: Nifedlipine
Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
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2: Active Comparator
Intravenous Magnesium
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Drug: Magnesium
Intravenous Magnesium 6 gram load, 3 grams/hr
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (>4 uterine contractions in 20 minutes):
Exclusion Criteria:
Contact: Christine Preslicka, RN | 56-933-2755 | cpreslicka@memorialcare.org |
United States, California | |
Memorial Care Center for Women/Long Beach Memorial Medical Center | |
Long Beach, California, United States, 92806 |
Principal Investigator: | Kenneth Chan, MD | Obstetrix/Memorial Care |
Principal Investigator: | Vineet K Shrivastava, MD | University of California, Irvine |
Responsible Party: | Obstetrix (Magella) ( Kenneth Chan ) |
Study ID Numbers: | 464-07 |
Study First Received: | March 19, 2008 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00641784 |
Health Authority: | United States: Institutional Review Board |
Composite Early neonatal Outcome Late Neurological neonatal outcome |
Pregnancy Complications Magnesium Sulfate Obstetric Labor, Premature Obstetric Labor Complications Nifedipine |