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Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia

Primary Purpose

Pregnancy, Preeclampsia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring pregnancy, preeclampsia, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

MetroHealth Medical Center, Labor and Delivery

Outcomes

Primary Outcome Measures

Time of magnesium sulfate therapy (minutes)

Blood pressure

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00344058

First Posted

June 23, 2006

Last Updated

June 23, 2006

Sponsor

Case Western Reserve University

1. Study Identification

Unique Protocol Identification Number

NCT00344058

Brief Title

Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Case Western Reserve University

4. Oversight

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, Preeclampsia

Keywords

pregnancy, preeclampsia, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Time of magnesium sulfate therapy (minutes)

Title

Blood pressure

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugh M Ehrenberg, MD

Organizational Affiliation

MetroHealth Medical Center at Case Western Reserve School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

MetroHealth Medical Center, Labor and Delivery

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17012443

Citation

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.

Results Reference

derived

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Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia

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