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OpenTrials
Completed

NCT Number: NCT00186069

Magnesium Sulfate vs Placebo for Placental Abruption

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

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Key information

Conditions

Abruptio Placentae Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Santa Clara Valley Medical Center, San Jose, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

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.

Other names: Active study drug

Normal Saline

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.

Other names: Normal Saline infusion as placebo

Primary outcomes

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

    Time frame: 48 hours after the randomization

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

Secondary outcomes

  1. Gestational Age at Delivery (Weeks)

    Time frame: Time of delivery

    Median gestational age at delivery (in full weeks)

  2. Neonatal Apgar Score at 5 Minutes

    Time frame: At 5 minutes after birth

    The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Santa Clara Valley Medical Center

Registry information

Official study title

Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption

Important dates

Study start
2004
Primary completion
2014
Study completion
2017
First posted
Sep 16, 2005
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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