Preterm Labor
Conditions
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.
Interventions
DRUGNifedipine
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.
DRUGPlacebo
Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.
OTHERUsual care
Usual evaluation, monitoring and care for women with preterm labor.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Preterm Birth | Less than 37 weeks of gestation |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Preterm Birth | Within 48 hours of randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nifedipine Women with preterm labor will receive nifedipine.
Nifedipine: 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.
Usual care: Usual evaluation, monitoring and care for women with preterm labor. | 46 |
| Placebo Women with preterm labor will receive placebo.
Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.
Usual care: Usual evaluation, monitoring and care for women with preterm labor. | 42 |
| Total | 88 |
Baseline characteristics
| Characteristic | Nifedipine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 37 Participants | 82 Participants |
| Age, Continuous | 25.5 years STANDARD_DEVIATION 5.8 | 26.7 years STANDARD_DEVIATION 6.7 | 26.1 years STANDARD_DEVIATION 6.2 |
| Race/Ethnicity, Customized Black | 10 Participants | 6 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic | 35 Participants | 35 Participants | 70 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 46 participants | 42 participants | 88 participants |
| Sex: Female, Male Female | 46 Participants | 42 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 42 |
| other Total, other adverse events | 0 / 46 | 0 / 42 |
| serious Total, serious adverse events | 0 / 46 | 0 / 42 |
Outcome results
Primary
Number of Participants With Preterm Birth
Time frame: Less than 37 weeks of gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Participants With Preterm Birth | 24 Participants |
| Placebo | Number of Participants With Preterm Birth | 20 Participants |
Secondary
Number of Participants With Preterm Birth
Time frame: Within 48 hours of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Participants With Preterm Birth | 8 Participants |
| Placebo | Number of Participants With Preterm Birth | 10 Participants |
Secondary
Number of Participants With Preterm Birth
Time frame: At least 2 doses of betamethasone administered prior to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Participants With Preterm Birth | 36 Participants |
| Placebo | Number of Participants With Preterm Birth | 31 Participants |
Secondary
Number of Participants With Preterm Birth
Time frame: Within 7 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Participants With Preterm Birth | 13 Participants |
| Placebo | Number of Participants With Preterm Birth | 14 Participants |