Magnesium Sulfate vs Placebo for Placental Abruption

NCT ID: NCT00186069

Last Updated: 2018-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.

Conditions

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Abruptio Placentae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Magnesium Sulfate

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

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

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.

Normal Saline

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

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.

Interventions

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Magnesium Sulfate

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.

Intervention Type DRUG

Normal Saline

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.

Intervention Type OTHER

Other Intervention Names

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Active study drug Normal Saline infusion as placebo

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Santa Clara Valley Medical Center

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Yasser Yehia El-Sayed

Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasser Y El-Sayed, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Santa Clara Valley Medical Center

San Jose, California, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26871905 (View on PubMed)

Other Identifiers

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79811

Identifier Type: -

Identifier Source: org_study_id

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