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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 19, 2008

Last Updated Date

March 21, 2008

Start Date ^†

March 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00641784 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Obstetric Labor, Premature

Intervention ^†

Drug: Magnesium
Drug: Nifedlipine

Study Arms / Comparison Groups

Experimental: Oral Nifedine
Active Comparator: Intravenous Magnesium

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

200

Completion Date

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Female

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Christine Preslicka, RN

56-933-2755

cpreslicka@memorialcare.org

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00641784

Responsible Party

Kenneth Chan, Obstetrix (Magella)

Secondary IDs ^††

Study Sponsor ^†

MemorialCare

Collaborators ^††

Investigators ^†

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

Information Provided By

MemorialCare

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.