Phase 3
Completed N=88
Nifedipine for Acute Tocolysis of Preterm Labor
Preterm Labor
Source: ClinicalTrials.gov NCT02132533 ↗
Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Preterm Birth — 24; 20 Participants
◆ Published Evidence
Established
65citations · ~16 / year
Tocolytics for delaying preterm birth: a network meta-analysis (0924).
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.
Linked Publications (2)
-
Tocolytics for delaying preterm birth: a network meta-analysis (0924).
-
Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Preterm Birth |
13; 14 | — |
| SECONDARY Number of Participants With Preterm Birth |
13; 14 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02132533) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.