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Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population

Information source: MemorialCare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Labor, Premature

Intervention: Magnesium (Drug); Nifedlipine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: MemorialCare

Official(s) and/or principal investigator(s):
Kenneth Chan, MD, Principal Investigator, Affiliation: Obstetrix/Memorial Care
Vineet K Shrivastava, MD, Principal Investigator, Affiliation: University of California, Irvine

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.

To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.

To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

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

Locations and Contacts

Memorial Care Center for Women/Long Beach Memorial Medical Center, Long Beach, California 92806, United States
Additional Information

Starting date: March 2008
Last updated: September 17, 2009

Page last updated: August 23, 2015

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