Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premature Birth; Premature Labor
Intervention: Magnesium sulfate (Drug); Oral Nifedipine or placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Baha Sibai, MD, Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
Rose Maxwell, PhD, Phone: 513-584-4509, Email: rose.maxwell@uc.edu
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation
Secondary outcome: Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity
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.
Eligibility
Minimum age: 15 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Rose Maxwell, PhD, Phone: 513-584-4509, Email: rose.maxwell@uc.edu
University Hospital, Cincinnati, Ohio 45219, United States; Recruiting
Caroline Stella, MD, Sub-Investigator
Baha Sibai, MD, Sub-Investigator
Additional Information
Related publications: 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.
Starting date: March 2006
Ending date: December 2010
Last updated: March 3, 2009
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