Abbreviated MgSO4 Therapy in Post-partum Preeclampsia

NCT ID: NCT00344058

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Pregnancy Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugh M Ehrenberg, MD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center at Case Western Reserve School of Medicine

Locations

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MetroHealth Medical Center, Labor and Delivery

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Ehrenberg HM, Mercer BM. Abbreviated postpartum magnesium sulfate therapy for women with mild preeclampsia: a randomized controlled trial. Obstet Gynecol. 2006 Oct;108(4):833-8. doi: 10.1097/01.AOG.0000236493.35347.d8.

Reference Type DERIVED
PMID: 17012443 (View on PubMed)

Other Identifiers

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IRB 01001-OBG-01

Identifier Type: -

Identifier Source: org_study_id

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