NCT00306462

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

Enrollment Period

3.6 years

First QC Date

March 21, 2006

Last Update Submit

November 6, 2009

Conditions

Premature BirthPremature Labor

Keywords

Premature LaborPremature BirthMagnesium sulfateNifedipine

Outcome Measures

Primary Outcomes (1)

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

    4 years

Secondary Outcomes (1)

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

    4 years and 9 months

Study Arms (2)

1

ACTIVE COMPARATOR

Intravenous magnesium sulfate or placebo

Drug: Magnesium sulfate

2

ACTIVE COMPARATOR

Oral nifedipine or placebo

Drug: Oral Nifedipine or placebo

Interventions

Magnesium sulfateDRUG

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.

1
Oral Nifedipine or placeboDRUG

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.

Also known as: Oral procardia
2

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (11)

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

    PMID: 10796110BACKGROUND

  • 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.

    PMID: 12519550BACKGROUND

  • 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.

    PMID: 14714923BACKGROUND

  • 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.

    PMID: 12535434BACKGROUND

  • 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.

    PMID: 8333483BACKGROUND

  • 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.

    PMID: 10725475BACKGROUND

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

    PMID: 11561911BACKGROUND

  • 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.

    PMID: 8238157RESULT

  • 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.

    PMID: 10580682RESULT

  • 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.

    PMID: 10601925RESULT

  • 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.

    PMID: 35947046DERIVED

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Interventions

Magnesium SulfateNifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Baha Sibai, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 23, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 9, 2009

Record last verified: 2009-11

Locations

US(1)