Pre-eclampsiaPhase 3NCT01846156
New Magnesium Sulphate Protocol for Pre-eclampsia
A Phase 3 study testing MgSO4 in people with Pre-eclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Pre-eclampsia
- What is being tested?
- MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- May 2013to Apr 2014
- Phase
- Phase 3
- 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 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant females ≥20 weeks of gestation.
- Pregnant females with criteria of severe pre-eclampsia.
- Single or multi-fetal pregnancy.
- Primigravida or Multigravida.
Who cannot join
- Pregnant females < 20 weeks gestation.
- Pregnant females with history of epilepsy.
- Pregnant females with diabetes.
- Pregnant females with chronic hypertension.
- Pregnant females with renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol
Read the detailed description
The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.
The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-
- Systolic blood pressure ≥ 160.
- Diastolic blood pressure ≥ 110.
- Proteinuria > +2 by dip stick.
- Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).
- Fetal growth restriction (IUGR).
After obtaining an informed consent the patients will be subjected to the following:
- Careful history taking including age, parity, gestational age.
- Complete physical examination and assessment of the blood pressure.
- Urine analysis by dipstick.
- All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .
Using Random Number Table, the sample size will be divided into three categories:-
- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.
- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate.
Inclusion criteria:
- Pregnant females ≥20 weeks of gestation.
- Pregnant females with criteria of severe pre-eclampsia.
- Single or multi-fetal pregnancy.
- Primigravida or Multigravida.
Exclusion criteria:
- Pregnant females < 20 weeks gestation.
- Pregnant females with history of epilepsy.
- Pregnant females with diabetes.
- Pregnant females with chronic hypertension.
- Pregnant females with renal disease.
- Conditions
- Pre-eclampsia
- Being tested
- MgSO4
- Keywords
- convulsion rate
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSO4Drug
A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University
| Study group | Role | What they receive |
|---|---|---|
| Abrreviated MgSO4 protocol | Experimental | - Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period. Receives: Drug: MgSO4 |
| No maintenance protocol | Experimental | - Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate Receives: Drug: MgSO4 |
| standard MgSO4 protocol | Active comparator | - Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period. Receives: Drug: MgSO4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of MgSo4 treatment
treatment duration
Measured: 1 year
Secondary outcomes (1)
ICU admission
ICU admission
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 2014
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 Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-khayat, Cairo University
- Investigators
- Waleed El-khayat, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846156
- Sponsor's protocol ID
- 52103
- Other IDs
- 52013
- Status last verified
- Aug 2014
- First submitted
- 1 May 2013
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
PubMed 37815037
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01846156
- Acronym / sponsor ID
- 52103
- Conditions
- Pre-eclampsia
- Keywords
- convulsion rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 May 2013 (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.
there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol
Detailed description
The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.
The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-
- Systolic blood pressure ≥ 160.
- Diastolic blood pressure ≥ 110.
- Proteinuria > +2 by dip stick.
- Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).
- Fetal growth restriction (IUGR).
After obtaining an informed consent the patients will be subjected to the following:
- Careful history taking including age, parity, gestational age.
- Complete physical examination and assessment of the blood pressure.
- Urine analysis by dipstick.
- All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .
Using Random Number Table, the sample size will be divided into three categories:-
- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.
- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate.
Inclusion criteria:
- Pregnant females ≥20 weeks of gestation.
- Pregnant females with criteria of severe pre-eclampsia.
- Single or multi-fetal pregnancy.
- Primigravida or Multigravida.
Exclusion criteria:
- Pregnant females < 20 weeks gestation.
- Pregnant females with history of epilepsy.
- Pregnant females with diabetes.
- Pregnant females with chronic hypertension.
- Pregnant females with renal disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abrreviated MgSO4 protocol | Experimental | Drug: MgSO4- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period. |
| No maintenance protocol | Experimental | Drug: MgSO4- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate |
| standard MgSO4 protocol | Active comparator | Drug: MgSO4- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant females ≥20 weeks of gestation.
- Pregnant females with criteria of severe pre-eclampsia.
- Single or multi-fetal pregnancy.
- Primigravida or Multigravida.
Key exclusion criteria (5 listed)
- Pregnant females < 20 weeks gestation.
- Pregnant females with history of epilepsy.
- Pregnant females with diabetes.
- Pregnant females with chronic hypertension.
- Pregnant females with renal disease.
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 |
|---|---|---|
| MgSO4A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University | Drug | Abrreviated MgSO4 protocol, No maintenance protocol, standard MgSO4 protocol |
Primary outcome
duration of MgSo4 treatment
Time frame: 1 year
treatment duration
1 secondary outcome
ICU admission
Time frame: 1 year
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 22 Aug 2014.
- Derived from this study: PubMed 37815037Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
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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.
Waleed El-khayat, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MgSO4 in people with Pre-eclampsia, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 5 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 22 Aug 2014. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
duration of MgSo4 treatment (time frame: 1 year). 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 NCT01846156, 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 22 Aug 2014.