Clinical trial NCT02132533: Nifedipine for Acute Tocolysis of Preterm Labor
Official title: Nifedipine for Acute Tocolysis of Preterm Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Labor
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 88
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Preterm Birth
timeFrame: Less than 37 weeks of gestation
Secondary outcomes:
measure: Number of Participants With Preterm Birth
timeFrame: Within 48 hours of randomization
measure: Number of Participants With Preterm Birth
timeFrame: At least 2 doses of betamethasone administered prior to delivery
measure: Number of Participants With Preterm Birth
timeFrame: Within 7 days of randomization
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: Department of Alabama Medical Center, Birmingham, AL
name: Brian M Casey, MD
role: STUDY_DIRECTOR
affiliation: University of Texas Southwestern Medical Center
name: Donald D McIntire, PhD
role: STUDY_DIRECTOR
affiliation: University of Texas Southwestern Medical Center
name: Kenneth J Leveno, MD
role: STUDY_DIRECTOR
affiliation: University of Texas Southwestern Medical Center
name: Chet E Wells, MD
role: STUDY_DIRECTOR
affiliation: Kaiser Medical Center, Oakland, CA
name: Josiah S Hawkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
citation: Hawkins JS, Wells CE, Casey BM, McIntire DD, Leveno KJ. Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial. Obstet Gynecol. 2021 Jul 1;138(1):73-78. doi: 10.1097/AOG.0000000000004436.