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

Primary Purpose

Premature Birth, Premature Labor

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnesium sulfate

Oral Nifedipine or placebo

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Premature Labor, Premature Birth, Magnesium sulfate, Nifedipine

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Intravenous magnesium sulfate or placebo

Oral nifedipine or placebo

Outcomes

Primary Outcome Measures

Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation

Secondary Outcome Measures

Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity

Full Information

NCT ID

NCT00306462

First Posted

March 21, 2006

Last Updated

November 6, 2009

Sponsor

University of Cincinnati

Collaborators

University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00306462

Brief Title

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

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Terminated

Why Stopped

No enrollment in past year, lack of interest

Study Start Date

March 2006 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cincinnati

Collaborators

University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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: To compare maternal side effects between the two tocolytic agents To compare neonatal morbidities between the two study groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth, Premature Labor

Keywords

Premature Labor, Premature Birth, Magnesium sulfate, Nifedipine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Intravenous magnesium sulfate or placebo

Arm Title

Arm Type

Active Comparator

Arm Description

Oral nifedipine or placebo

Intervention Type

Drug

Intervention Name(s)

Magnesium sulfate

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Oral Nifedipine or placebo

Other Intervention Name(s)

Oral procardia

Intervention Description

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.

Primary Outcome Measure Information:

Title

Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity

Time Frame

4 years and 9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baha Sibai, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10796110

Citation

Crowley P. Prophylactic corticosteroids for preterm birth. Cochrane Database Syst Rev. 2000;(2):CD000065. doi: 10.1002/14651858.CD000065.

Results Reference

background

PubMed Identifier

12519550

Citation

Crowther CA, Hiller JE, Doyle LW. Magnesium sulphate for preventing preterm birth in threatened preterm labour. Cochrane Database Syst Rev. 2002;(4):CD001060. doi: 10.1002/14651858.CD001060.

Results Reference

background

PubMed Identifier

14714923

Citation

Huddleston JF, Sanchez-Ramos L, Huddleston KW. Acute management of preterm labor. Clin Perinatol. 2003 Dec;30(4):803-24, vii. doi: 10.1016/s0095-5108(03)00114-3.

Results Reference

background

PubMed Identifier

12535434

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. doi: 10.1002/14651858.CD002255.

Results Reference

background

PubMed Identifier

8333483

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. doi: 10.1016/0002-9378(93)90138-9.

Results Reference

background

PubMed Identifier

10725475

Citation

Papatsonis DN, Kok JH, van Geijn HP, Bleker OP, Ader HJ, Dekker GA. Neonatal effects of nifedipine and ritodrine for preterm labor. Obstet Gynecol. 2000 Apr;95(4):477-81. doi: 10.1016/s0029-7844(99)00596-7.

Results Reference

background

PubMed Identifier

11561911

Citation

Ramsey PS, Rouse DJ. Magnesium sulfate as a tocolytic agent. Semin Perinatol. 2001 Aug;25(4):236-47. doi: 10.1053/sper.2001.27546.

Results Reference

background

PubMed Identifier

8238157

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.

Results Reference

result

PubMed Identifier

10580682

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.

Results Reference

result

PubMed Identifier

10601925

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.

Results Reference

result

PubMed Identifier

35947046

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.

Results Reference

derived

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

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