Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor - Tabular View

Tracking Information

First Received Date ^ICMJE

March 21, 2006

Last Updated Date

November 6, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation

Change History

Complete list of historical versions of study NCT00306462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity [ Time Frame: 4 years and 9 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Neonatal outcomes

Descriptive Information

Brief Title ^ICMJE

Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor

Official Title ^ICMJE

Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation

Brief Summary

Primary Hypothesis:

Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.

Detailed Description

Primary Objective:

To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at <37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation.

Secondary Objective:

To compare maternal side effects between the two tocolytic agents
To compare neonatal morbidities between the two study groups.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Premature Birth
Premature Labor

Intervention ^ICMJE

Drug: Magnesium sulfate
Drug: Oral Nifedipine or placebo

Study Arms / Comparison Groups

Active Comparator: Intravenous magnesium sulfate or placebo
Active Comparator: Oral nifedipine or placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old.

Exclusion Criteria:

Cervical dilatation of ≥ 6 cm
Maternal contraindication to tocolysis
Known fetal anomalies
Suspected chorioamnionitis
Nonreassuring fetal heart tracing
Vaginal bleeding due to placenta previa or abruptio placenta
Preterm premature rupture of membranes
Prolapsed membranes
Human immunodeficiency virus positive
Multiple gestation
Patients on procardia within 24 hours of po intake
Magnesium sulfate tocolysis prior to randomization
Patient refusal

Gender

Female

Ages

15 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00306462

Responsible Party

Baha Sibai, MD/Professor, University of Cincinnati

Study ID Numbers ^ICMJE

05-12-27-01

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

University Hospital

Investigators ^ICMJE

Principal Investigator:

Baha Sibai, MD

University of Cincinnati

Information Provided By

University of Cincinnati

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP