Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population - Full Text View

Sponsor:	MemorialCare
Information provided by:	MemorialCare
ClinicalTrials.gov Identifier:	NCT00641784

Purpose

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
Labor, Premature	Drug: Magnesium Drug: Nifedlipine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Magnesium

U.S. FDA Resources

Further study details as provided by MemorialCare:

Primary Outcome Measures:

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 [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor. [ Time Frame: At Delivery ] [ Designated as safety issue: No ]
To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate. [ Time Frame: At delivery ] [ Designated as safety issue: No ]
To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis [ Time Frame: At discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral Nifedine	Drug: Nifedlipine Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
Active Comparator: 2 Intravenous Magnesium	Drug: Magnesium Intravenous Magnesium 6 gram load, 3 grams/hr

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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):
1. Cervix > 2 cm in dilation or 80% effaced
2. Positive fetal fibronectin (if performed).
3. Demonstrated cervical change between two exams within 90 minutes.

Exclusion Criteria:

Negative fetal fibronectin
> 5cm dilatation
Multiple gestations
Known fetal anomalies or chromosomal abnormalities
Ruptured membranes
Significant vaginal bleeding
Suspected chorioamnionitis
Preeclampsia or uncontrolled hypertension
Non-reassuring fetal heart tracing
Placenta previa and/or accreta
Placenta abruption
Intrauterine growth restriction
Maternal renal disease
Underlying maternal cardiac condition
Symptomatic hyperthyroidism
Significant maternal disease
Contraindication to nifedipine or magnesium
Cerclage presence
Tocolytic use within the last 12 hours
Hypotension (defined as average blood pressure of <70/40's unresponsive to 1000 cc fluid bolus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641784

Locations

United States, California
Memorial Care Center for Women/Long Beach Memorial Medical Center
Long Beach, California, United States, 92806

Sponsors and Collaborators

MemorialCare

Investigators

Principal Investigator:	Kenneth Chan, MD	Obstetrix/Memorial Care
Principal Investigator:	Vineet K Shrivastava, MD	University of California, Irvine

More Information

No publications provided

Responsible Party:	Kenneth Chan, Obstetrix (Magella)
ClinicalTrials.gov Identifier:	NCT00641784 History of Changes
Other Study ID Numbers:	464-07
Study First Received:	March 19, 2008
Last Updated:	September 17, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by MemorialCare:

Composite Early neonatal Outcome
Late Neurological neonatal outcome

Additional relevant MeSH terms:

Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on February 09, 2012