NCT00641784

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

March 19, 2008

Last Update Submit

September 17, 2009

Conditions

Labor, Premature

Keywords

Composite Early neonatal OutcomeLate Neurological neonatal outcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Oral Nifedine

Drug: Nifedlipine

2

ACTIVE COMPARATOR

Intravenous Magnesium

Drug: Magnesium

Interventions

MagnesiumDRUG

Intravenous Magnesium 6 gram load, 3 grams/hr

2
NifedlipineDRUG

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

1

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Care Center for Women/Long Beach Memorial Medical Center

Long Beach, California, 92806, United States

Location

Related Publications (1)

  • 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.

    PMID: 35947046DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Kenneth Chan, MD

    Obstetrix/Memorial Care

    PRINCIPAL INVESTIGATOR

  • Vineet K Shrivastava, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 24, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(1)