Nifedipine for Acute Tocolysis of Preterm Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.

Official Title
-----------------
Nifedipine for Acute Tocolysis of Preterm Labor

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: Nifedipine
* Drug: Placebo
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 16 and 44 years of age inclusive Singleton pregnancy Intact membranes Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive Reported or documented uterine activity Cervical dilation between 2 cm and 4 cm inclusive Exclusion Criteria: Multifetal gestation Less than 28 weeks' gestation 34 or more weeks' gestation Ruptured membranes More than 4 cm dilated Previously received a course of corticosteroids for fetal lung maturation Oligohydramnios Fetal growth restriction Chorioamnionitis or temperature of at least 38.0 degrees Celsius Fetal death Preeclampsia Suspected placental abruption or placenta previa Lethal fetal malformation or amniotic fluid index at least 35 Systolic BP < 90 mmHg or diastolic BP < 50 mmHg Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart) Chronic hypertension treated with antihypertensives in pregnancy Seizure disorder or HIV Maternal allergy to nifedipine Known maternal cardiac disease Women who have received progesterone therapy in the second or third trimester for prevention of preterm birth

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 44 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nifedipine<br>Women with preterm labor will receive nifedipine. | Drug: Nifedipine<br>* Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.<br>Other: Usual care<br>* Usual evaluation, monitoring and care for women with preterm labor.<br>|
| Experimental: Placebo<br>Women with preterm labor will receive placebo. | Drug: Placebo<br>* Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.<br>Other: Usual care<br>* Usual evaluation, monitoring and care for women with preterm labor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Preterm Birth |  | Less than 37 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Preterm Birth |  | Within 48 hours of randomization | 
| Number of Participants With Preterm Birth |  | At least 2 doses of betamethasone administered prior to delivery | 
| Number of Participants With Preterm Birth |  | Within 7 days of randomization |