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

Sponsors and Collaborators:	University of Cincinnati University Hospital
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00306462

Purpose

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	Intervention
Premature Birth Premature Labor	Drug: Magnesium sulfate Drug: Oral Nifedipine or placebo

Drug Information available for: Magnesium sulfate Nifedipine Magnesium

U.S. FDA Resources

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

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	154
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	15 Years to 50 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306462

Contacts

Contact: Rose Maxwell, PhD

513-584-4509

rose.maxwell@uc.edu

Locations

United States, Ohio
University Hospital	Recruiting
Cincinnati, Ohio, United States, 45219
Sub-Investigator: Caroline Stella, MD
Sub-Investigator: Baha Sibai, MD

Sponsors and Collaborators

University of Cincinnati

University Hospital

Investigators

Principal Investigator:

Baha Sibai, MD

University of Cincinnati

More Information

Publications:

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.

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

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

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.

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, Ader 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.

Responsible Party:	University of Cincinnati ( Baha Sibai, MD/Professor )
Study ID Numbers:	05-12-27-01
Study First Received:	March 21, 2006
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00306462 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

Premature Labor
Premature Birth
Magnesium sulfate
Nifedipine

Study placed in the following topic categories:

Vasodilator Agents
Pregnancy Complications
Obstetric Labor, Premature
Magnesium Sulfate
Obstetric Labor Complications
Calcium Channel Blockers
Anesthetics
Central Nervous System Depressants

Cardiovascular Agents
Nifedipine
Calcium, Dietary
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Anticonvulsants
Premature Birth

Additional relevant MeSH terms:

Vasodilator Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Obstetric Labor, Premature
Magnesium Sulfate
Physiological Effects of Drugs
Obstetric Labor Complications
Calcium Channel Blockers
Central Nervous System Depressants
Anesthetics
Reproductive Control Agents
Cardiovascular Agents

Nifedipine
Pharmacologic Actions
Membrane Transport Modulators
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Premature Birth

ClinicalTrials.gov processed this record on May 07, 2009