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

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
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: Terminated

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Baha Sibai, MD, Principal Investigator, Affiliation: University of Cincinnati

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

University Hospital, Cincinnati, Ohio 45219, United States
Additional Information

Related publications:

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

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.

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. Update in: Cochrane Database Syst Rev. 2014;6:CD002255.

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, Adèr 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
Last updated: November 6, 2009

Page last updated: August 23, 2015

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