NCT00186069

Brief Summary

To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 20, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

10.3 years

First QC Date

September 13, 2005

Results QC Date

October 12, 2016

Last Update Submit

December 1, 2017

Conditions

Abruptio Placentae

Outcome Measures

Primary Outcomes (1)

  • Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours

    The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.

    48 hours after the randomization

Secondary Outcomes (2)

  • Gestational Age at Delivery (Weeks)

    Time of delivery

  • Neonatal Apgar Score at 5 Minutes

    At 5 minutes after birth

Study Arms (2)

Magnesium Sulfate

ACTIVE COMPARATOR

Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour

Drug: Magnesium Sulfate

Normal Saline

PLACEBO COMPARATOR

Normal Saline 4 gram bolus, followed by 2 grams per hour

Other: Normal Saline

Interventions

Magnesium SulfateDRUG

Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.

Also known as: Active study drug
Magnesium Sulfate
Normal SalineOTHER

Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.

Also known as: Normal Saline infusion as placebo
Normal Saline

Eligibility Criteria

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

You may qualify if:

  • \- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.

You may not qualify if:

  • \- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Colon I, Berletti M, Garabedian MJ, Wilcox N, Williams K, El-Sayed YY, Chueh J. Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption. Am J Perinatol. 2016 Jun;33(7):696-702. doi: 10.1055/s-0036-1571324. Epub 2016 Feb 12.

    PMID: 26871905DERIVED

MeSH Terms

Conditions

Abruptio Placentae

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Anna Girsen, Manager of Research Operations
Organization
Stanford University
agirsen@stanford.edu
(650) 725-5720

Study Officials

  • Yasser Y El-Sayed, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2004

Primary Completion

June 1, 2014

Study Completion

November 1, 2017

Last Updated

January 2, 2018

Results First Posted

April 20, 2017

Record last verified: 2017-12

Locations

US(2)