PregnancyNCT00344058
Abbreviated MgSO4 Therapy in Post-partum Preeclampsia
A study testing abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery) in people with Pregnancy and Preeclampsia, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Preeclampsia
- What is being tested?
- abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Aug 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with suspected mild preeclampsia diagnosed antepartum, intrapartum, or post-partum were eligible for inclusion after delivery at term (≥ 34 weeks' gestational age).
Who cannot join
- Inability to give informed consent, preterm delivery, severe preeclampsia
Trial locations and contacts
1 site in 1 country.
United States1 site
MetroHealth Medical Center, Labor and Delivery
Cleveland, Ohio, 44109
About this study
Official title: Abbreviated Post-partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens
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.
Read the 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
- Conditions
- Pregnancy, Preeclampsia
- Being tested
- abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)
- Keywords
- pregnancy, preeclampsia, treatment
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of magnesium sulfate therapy (minutes)
Blood pressure
Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startJan 2001
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugh M Ehrenberg, MD, Principal investigator, MetroHealth Medical Center at Case Western Reserve School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344058
- Sponsor's protocol ID
- IRB 01001-OBG-01
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2006
- Last updated
- 10 Sep 2025
- Results posted
- No
Publications
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.
PubMed 17012443
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbreviated Post-partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens
- ClinicalTrials.gov ID
- NCT00344058
- Acronym / sponsor ID
- IRB 01001-OBG-01
- Conditions
- Pregnancy, Preeclampsia
- Keywords
- pregnancy, preeclampsia, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Jan 2001 (actual)
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with suspected mild preeclampsia diagnosed antepartum, intrapartum, or post-partum were eligible for inclusion after delivery at term (≥ 34 weeks' gestational age).
Key exclusion criteria (1 listed)
- Inability to give informed consent, preterm delivery, severe preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery) | Drug | – |
Primary outcome
Time of magnesium sulfate therapy (minutes)
Blood pressure
Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 17012443Ehrenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh M Ehrenberg, MD principal investigator
MetroHealth Medical Center at Case Western Reserve School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery) in people with Pregnancy and Preeclampsia, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of magnesium sulfate therapy (minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.