Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia

This study has been completed.
Sponsor:
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00344058
First received: June 23, 2006
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Pregnancy
Preeclampsia
Drug: abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abbreviated Post-Partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Time of magnesium sulfate therapy (minutes)
  • Blood pressure
  • Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)

Estimated Enrollment: 200
Study Start Date: January 2001
Estimated Study Completion Date: August 2004
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344058

Locations
United States, Ohio
MetroHealth Medical Center, Labor and Delivery
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Hugh M Ehrenberg, MD MetroHealth Medical Center at Case Western Reserve School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00344058     History of Changes
Other Study ID Numbers: IRB 01001-OBG-01
Study First Received: June 23, 2006
Last Updated: June 23, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
pregnancy
preeclampsia
treatment

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 01, 2014