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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00306462
Other study ID # 05-12-27-01
Secondary ID
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
Health authority
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

Study Design


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
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