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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641784

Enrollment

200

Registered

2008-03-24

Start date

2008-03-31

Completion date

2012-03-31

Last updated

2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Premature

Keywords

Composite Early neonatal Outcome, Late Neurological neonatal outcome

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

Interventions

DRUGMagnesium

Intravenous Magnesium 6 gram load, 3 grams/hr

DRUGNifedlipine

Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	At delivery

Secondary

Measure	Time frame
To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.	At Delivery
To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.	At delivery
To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis	At discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026