Clinical trial NCT00641784: Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population
Official title: A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Labor, Premature
Keywords: Composite Early neonatal Outcome
Late Neurological neonatal outcome
Lead sponsor: MemorialCare
Sponsor class: OTHER
First posted: 2008-03-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures


Eligibility criteria: Inclusion Criteria:

* Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (\>4 uterine contractions in 20 minutes):

  1. Cervix \> 2 cm in dilation or 80% effaced
  2. Positive fetal fibronectin (if performed).
  3. Demonstrated cervical change between two exams within 90 minutes.

Exclusion Criteria:

* Negative fetal fibronectin
* \> 5cm dilatation
* Multiple gestations
* Known fetal anomalies or chromosomal abnormalities
* Ruptured membranes
* Significant vaginal bleeding
* Suspected chorioamnionitis
* Preeclampsia or uncontrolled hypertension
* Non-reassuring fetal heart tracing
* Placenta previa and/or accreta
* Placenta abruption
* Intrauterine growth restriction
* Maternal renal disease
* Underlying maternal cardiac condition
* Symptomatic hyperthyroidism
* Significant maternal disease
* Contraindication to nifedipine or magnesium
* Cerclage presence
* Tocolytic use within the last 12 hours
* Hypotension (defined as average blood pressure of \<70/40's unresponsive to 1000 cc fluid bolus

Primary outcomes:
measure: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
timeFrame: At delivery
Secondary outcomes:
measure: To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.
timeFrame: At Delivery
measure: To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.
timeFrame: At delivery
measure: To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis
timeFrame: At discharge
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Memorial Care Center for Women/Long Beach Memorial Medical Center
state: California
Study officials:
affiliation: Obstetrix/Memorial Care
name: Kenneth Chan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Vineet K Shrivastava, 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.