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

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ClinicalTrials.gov Identifier: NCT00306462

Recruitment Status : Terminated (No enrollment in past year, lack of interest)

First Posted : March 23, 2006

Last Update Posted : November 9, 2009

Sponsor:

Collaborator:

University Hospital

Information provided by:

University of Cincinnati

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Premature Birth Premature Labor	Drug: Magnesium sulfate Drug: Oral Nifedipine or placebo	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	33 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation
Study Start Date :	March 2006
Actual Primary Completion Date :	October 2009
Actual Study Completion Date :	October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium Magnesium sulfate Sulfate ion Nifedipine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 Intravenous magnesium sulfate or placebo	Drug: Magnesium sulfate Intravenous magnesium sulfate 6g bolus, then increased by 1 g/hour till a maximum of 5g/hour; gradually wean down to 2 g/hour for a total of 48 hours once uterine contractions is < 6/hour.
Active Comparator: 2 Oral nifedipine or placebo	Drug: Oral Nifedipine or placebo Oral nifedipine or placebo at 20 mg every 30 minutes for the first hour, then 20 mg every 3 to 6 hours not to exceed 180 mg in 24 hours, keep maintenance dose at 20 mg every 3 to 6 hours for a total of 48 hours if uterine contractions is < 6/hour. Other Name: Oral procardia

Outcome Measures

Primary Outcome Measures :

Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation [ Time Frame: 4 years ]

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	15 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306462

Locations

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United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219

Sponsors and Collaborators

University of Cincinnati

University Hospital

Investigators

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Principal Investigator:	Baha Sibai, MD	University of Cincinnati

More Information

Publications of Results:

Glock JL, Morales WJ. Efficacy and safety of nifedipine versus magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993 Oct;169(4):960-4.

Haghighi L. Prevention of preterm delivery: nifedipine or magnesium sulfate. Int J Gynaecol Obstet. 1999 Sep;66(3):297-8.

Larmon JE, Ross BS, May WL, Dickerson GA, Fischer RG, Morrison JC. Oral nicardipine versus intravenous magnesium sulfate for the treatment of preterm labor. Am J Obstet Gynecol. 1999 Dec;181(6):1432-7.

Other Publications:

Crowley P. Prophylactic corticosteroids for preterm birth. Cochrane Database Syst Rev. 2000;(2):CD000065. Review. Update in: Cochrane Database Syst Rev. 2006;(3):CD000065.

Crowther CA, Hiller JE, Doyle LW. Magnesium sulphate for preventing preterm birth in threatened preterm labour. Cochrane Database Syst Rev. 2002;(4):CD001060. Review. Update in: Cochrane Database Syst Rev. 2014;8:CD001060.

Huddleston JF, Sanchez-Ramos L, Huddleston KW. Acute management of preterm labor. Clin Perinatol. 2003 Dec;30(4):803-24, vii. Review.

King JF, Flenady VJ, Papatsonis DN, Dekker GA, Carbonne B. Calcium channel blockers for inhibiting preterm labour. Cochrane Database Syst Rev. 2003;(1):CD002255. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD002255.

Morales WJ, Madhav H. Efficacy and safety of indomethacin compared with magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993 Jul;169(1):97-102.

Papatsonis DN, Kok JH, van Geijn HP, Bleker OP, Adèr HJ, Dekker GA. Neonatal effects of nifedipine and ritodrine for preterm labor. Obstet Gynecol. 2000 Apr;95(4):477-81.

Ramsey PS, Rouse DJ. Magnesium sulfate as a tocolytic agent. Semin Perinatol. 2001 Aug;25(4):236-47. Review.

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Responsible Party:	Baha Sibai, MD/Professor, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00306462 History of Changes
Other Study ID Numbers:	05-12-27-01
First Posted:	March 23, 2006 Key Record Dates
Last Update Posted:	November 9, 2009
Last Verified:	November 2009

Keywords provided by University of Cincinnati:


Premature Labor Premature Birth Magnesium sulfate Nifedipine

Additional relevant MeSH terms:

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Nifedipine Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics	Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents Vasodilator Agents

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