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Completed

NCT Number: NCT00344058

Abbreviated MgSO4 Therapy in Post-partum Preeclampsia

Magnesium sulfate is used for seizure prophylaxis in pregnancies complicated by preeclampsia. There is debate as to how long to continue this therapy after delivery of the pregnancy. Different schemes have been offered to shorten the exposure to magnesium sulfate after delivery, with little data. We seek to investigate the effect of shortened magnesium sulfate therapy on the post-partum recovery phase of mild preeclampsia. Our hypothesis was that shortened therapy (12 hours versus the traditional 24 hours post-partum) has no effect on disease course, and will result in significantly shorter exposure to magnesium sulfate.

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Key information

Conditions

Pregnancy Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth Medical Center, Labor and Delivery

Cleveland, Ohio, 44109, United States

About this study

The study has been completed at this time.

Consenting women with suspected mild preeclampsia (new onset/exacerbated hypertension with proteinuria) were randomly assigned 12 (12-hour) or 24-hours (24-hour) of postpartum MgSO4. Treatment was continued beyond the initially assigned time period for new findings of severe preeclampsia. Clinical and laboratory data were collected. Analysis was by intent to treat, utilizing Fisher's exact, chi-square, and Student's t-tests where appropriate

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with suspected mild preeclampsia diagnosed antepartum, intrapartum, or post-partum were eligible for inclusion after delivery at term (≥ 34 weeks' gestational age).

Exclusion criteria

  • Inability to give informed consent, preterm delivery, severe preeclampsia

Treatment and study plan

abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)

Drug

Primary outcomes

  1. Time of magnesium sulfate therapy (minutes)

  2. Blood pressure

  3. Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

Abbreviated Post-partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Jun 26, 2006
Registry last updated
Sep 10, 2025

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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