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...
Date First Received: March 21, 2006
Last Updated: July 28, 2008
Verified by: University of Cincinnati, July 2008
Clinical Trial Phase: N/A | Start Date: March 2006
Overall Status: Recruiting
Estimated Enrollment: 154
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: March 2010
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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.
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Intravenous magnesium sulfate or placebo
- Active Comparator: 2
- Oral nifedipine or placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation
- Time Frame: 4 years
Safety Issue?: Yes
- Time Frame: 4 years
Secondary Measures
- Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity
- Time Frame: 4 years and 9 months
Safety Issue?: Yes
- Time Frame: 4 years and 9 months
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 15 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of Cincinnati
Overall Clinical Trial Officials and Contacts
Helen How, MD Principal Investigator University of Cincinnati
Overall Contact: Gail Kushner 513-584-7242 gail.kushner@uc.edu
Related Publications
References
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.
Citations Reporting 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.
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00306462
Study ID Number: 05-12-27-01
ClinicalTrials.gov Identifier: NCT00306462
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
