NCT00185900

Brief Summary

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 1999

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
11.3 years until next milestone

Results Posted

Study results publicly available

October 2, 2018

Completed
Last Updated

November 19, 2018

Status Verified

October 1, 2018

Enrollment Period

6.3 years

First QC Date

September 12, 2005

Results QC Date

February 13, 2018

Last Update Submit

October 2, 2018

Conditions

Obstetric Labor, Premature

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence

    Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.

    48 hours after administration of study medication.

Secondary Outcomes (5)

  • Time to Uterine Quiescence

    Until delivery, up to 42 weeks of gestation

  • Gestational Age at Delivery

    Until delivery, up to 42 weeks of gestation

  • Neonatal Birth Weight

    Until delivery, up to 42 weeks of gestation

  • Serious Maternal Adverse Effect

    From study enrollment until discharge from delivery hospital, up to 30 days after delivery.

  • Composite Neonatal Morbidity

    From delivery until discharge from the hospital, up to 30 days of age

Study Arms (2)

Magnesium Sulfate

ACTIVE COMPARATOR

Preterm labor treatment with Magnesium Sulfate.

Drug: Magnesium Sulfate

Nifedipine

ACTIVE COMPARATOR

Preterm labor treatment with Nifedipine.

Drug: Nifedipine

Interventions

Magnesium SulfateDRUG

Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Magnesium Sulfate
NifedipineDRUG

Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Nifedipine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

  • Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, Burrs D, Caughey AB, El-Sayed YY. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7. doi: 10.1097/01.AOG.0000269048.06634.35.

    PMID: 17601897RESULT

  • 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

Related Links

MeSH Terms

Conditions

Obstetric 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

Results Point of Contact

Title
Dr. Anna Girsen
Organization
Stanford University
agirsen@stanford.edu
(650) 725-5720

Study Officials

  • Yasser Yehia El-Sayed

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

April 1, 1999

Primary Completion

July 1, 2005

Study Completion

July 1, 2007

Last Updated

November 19, 2018

Results First Posted

October 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)