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
Verified date | November 2009 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati | University Hospital |
United States,
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
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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