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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00306462
• Other study ID #: 05-12-27-01
• Status: Terminated
• Phase: N/A
• First received: March 21, 2006
• Last updated: November 6, 2009
• Start date: March 2006
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Premature Labor

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	University Hospital

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation		4 years
Secondary	Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity		4 years and 9 months