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

Study Overview
=================
Brief Summary
-----------------
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

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

Conditions
-----------------
Labor, Premature

Intervention / Treatment
-----------------
* Drug: Magnesium
* Drug: Nifedlipine


Participation Criteria
=================
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): Cervix > 2 cm in dilation or 80% effaced Positive fetal fibronectin (if performed). 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral Nifedine | Drug: Nifedlipine<br>* Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs<br>|
| Active Comparator: 2<br>Intravenous Magnesium | Drug: Magnesium<br>* Intravenous Magnesium 6 gram load, 3 grams/hr<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor. |  | At Delivery | 
| To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate. |  | At delivery | 
| To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis |  | At discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Composite Early neonatal Outcome, Late Neurological neonatal outcome