Back to resultsTocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population
Primary Purpose
Labor, Premature
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Magnesium
Nifedlipine
Sponsored by
About this trial
This is an interventional treatment trial for Labor, Premature focused on measuring Composite Early neonatal Outcome, Late Neurological neonatal outcome
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):
- Cervix > 2 cm in dilation or 80% effaced
- Positive fetal fibronectin (if performed).
- 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
Sites / Locations
- Memorial Care Center for Women/Long Beach Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Oral Nifedine
Intravenous Magnesium
Outcomes
Primary Outcome Measures
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 Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00641784
Brief Title
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
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
MemorialCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor, Premature
Keywords
Composite Early neonatal Outcome, Late Neurological neonatal outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral Nifedine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intravenous Magnesium
Intervention Type
Drug
Intervention Name(s)
Magnesium
Intervention Description
Intravenous Magnesium 6 gram load, 3 grams/hr
Intervention Type
Drug
Intervention Name(s)
Nifedlipine
Intervention Description
Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
Primary Outcome Measure Information:
Title
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
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.
Time Frame
At Delivery
Title
To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.
Time Frame
At delivery
Title
To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis
Time Frame
At discharge
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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):
Cervix > 2 cm in dilation or 80% effaced
Positive fetal fibronectin (if performed).
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Chan, MD
Organizational Affiliation
Obstetrix/Memorial Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vineet K Shrivastava, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Care Center for Women/Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
92806
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35947046
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.
Results Reference
derived
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Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population
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