Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor

Study Overview
=================
Brief Summary
-----------------
Primary Hypothesis: Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.

Detailed Description
-----------------
Primary Objective: To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at <37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation. Secondary Objective: To compare maternal side effects between the two tocolytic agents To compare neonatal morbidities between the two study groups.

Official Title
-----------------
Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation

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

Intervention / Treatment
-----------------
* Drug: Magnesium sulfate
* Drug: Oral Nifedipine or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old. Exclusion Criteria: Cervical dilatation of ≥ 6 cm Maternal contraindication to tocolysis Known fetal anomalies Suspected chorioamnionitis Nonreassuring fetal heart tracing Vaginal bleeding due to placenta previa or abruptio placenta Preterm premature rupture of membranes Prolapsed membranes Human immunodeficiency virus positive Multiple gestation Patients on procardia within 24 hours of po intake Magnesium sulfate tocolysis prior to randomization Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intravenous magnesium sulfate or placebo | Drug: Magnesium sulfate<br>* Intravenous magnesium sulfate 6g bolus, then increased by 1 g/hour till a maximum of 5g/hour; gradually wean down to 2 g/hour for a total of 48 hours once uterine contractions is < 6/hour.<br>|
| Active Comparator: 2<br>Oral nifedipine or placebo | Drug: Oral Nifedipine or placebo<br>* Oral nifedipine or placebo at 20 mg every 30 minutes for the first hour, then 20 mg every 3 to 6 hours not to exceed 180 mg in 24 hours, keep maintenance dose at 20 mg every 3 to 6 hours for a total of 48 hours if uterine contractions is < 6/hour.<br>* Other names: Oral procardia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity |  | 4 years and 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Labor, Premature Birth, Magnesium sulfate, Nifedipine