Clinical trial NCT00306462: Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Birth
Premature Labor
Keywords: Premature Labor
Premature Birth
Magnesium sulfate
Nifedipine
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: University Hospital
First posted: 2006-03-23
Enrollment: 33
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation
timeFrame: 4 years
Secondary outcomes:
measure: Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity
timeFrame: 4 years and 9 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Baha Sibai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1016/0002-9378(93)90035-h.
citation: Haghighi L. Prevention of preterm delivery: nifedipine or magnesium sulfate. Int J Gynaecol Obstet. 1999 Sep;66(3):297-8. doi: 10.1016/s0020-7292(99)00095-8.
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. doi: 10.1016/s0002-9378(99)70388-1.
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.