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

• Sponsor: University of Cincinnati (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00306462
• Collaborator: University Hospital (Other)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 0.8

Study Details

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	N/A

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:

1. To compare maternal side effects between the two tocolytic agents

2. To compare neonatal morbidities between the two study groups.

Study Design

• Study Type: Interventional
• 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: Mar 1, 2006
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

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 Names: Oral procardia

Outcome Measures

Primary Outcome Measures

1. Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation [4 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Cincinnati	Ohio	United States	45219

Sponsors and Collaborators

• University of Cincinnati
• University Hospital

Investigators

• Principal Investigator: Baha Sibai, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00306462
• Other Study ID Numbers: 05-12-27-01
• First Posted: Mar 23, 2006
• Last Update Posted: Nov 9, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Premature Labor; Premature Birth; Magnesium sulfate; Nifedipine
• Additional relevant MeSH terms: Premature Birth; Obstetric Labor, Premature; Magnesium Sulfate; Nifedipine

Study Results

No Results Posted as of Nov 9, 2009