PreeclampsiaPhase 4NCT02699827
Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia
A Phase 4 study testing Levobupivacaine hydrochloride, Magnesium sulphate and Saline 0.9% in people with Preeclampsia, run by Mohamed Sayed Abdelhafez at 1 site in Egypt.
Trial summary
This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Levobupivacaine hydrochloride, Magnesium sulphate and Saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Jan 2017
- Phase
- Phase 4
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with preeclampsia undergoing elective CS.
Who cannot join
- Age < 20 or > 35 years.
- Height < 150 or > 180 cm.
- Body mass index (BMI) > 35 kg/m2.
- Active labor.
- Multifetal pregnancy.
- Fetal distress.
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- Medical conditions complicating pregnancy.
- HELLP syndrome.
- Thrombocytopenia.
- Hepatic or renal impairment.
- Pulmonary edema or cyanosis.
- Placenta previa.
- Vaginal bleeding or placental abruption.
- Contraindication for central neuraxial block.
- History of adverse reaction to any study medication.
- History of analgesic use.
- Magnesium therapy.
- Chronic pain syndrome.
- Presence of communication difficulties preventing reliable assessment.
- Refusal to undergo regional anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Adding Magnesium Sulphate to Epidural Levobupivacaine in Elective Caesarian Section for Patients With Preeclampsia
This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS).
Read the detailed description
Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All patients participating in the study will be randomly divided into two groups; magnesium sulphate group (study group) and placebo group (control group). Patients in the study group will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate 10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml saline 0.9%.
- Conditions
- Preeclampsia
- Being tested
- Levobupivacaine hydrochloride, Magnesium sulphate, Saline 0.9%
- Keywords
- Levobupivacaine, Magnesium, Preeclampsia, Epidural
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine hydrochlorideDrug
Also called Chirocaine
Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%
Magnesium sulphateDrug
Patients will receive epidural 5 ml magnesium sulphate 10%
Saline 0.9%Drug
Patients will receive epidural 5 ml saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate group | Active comparator | Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate Receives: Drug: Levobupivacaine hydrochloride; Drug: Magnesium sulphate |
| Placebo group | Placebo comparator | Patients will receive epidural levobupivacaine hydrochloride + saline 0.9% Receives: Drug: Levobupivacaine hydrochloride; Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-free period
The time from reaching sensory block to onset of pain
Measured: 24 hours after the epidural anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Tamer Elmetwally, Dr, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura UniversityReem A Elsharkawy, Dr, Study director, Mansoura UniversityWaleed El-refaie, Dr, Study director, Mansoura UniversityAlaa Wageeh, Dr, Study director, Mansoura UniversitySalwa S Hays, Prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699827
- Sponsor's protocol ID
- TM1
- Status last verified
- Jun 2017
- First submitted
- 1 Mar 2016
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Magnesium Sulphate to Epidural Levobupivacaine in Elective Caesarian Section for Patients With Preeclampsia
- ClinicalTrials.gov ID
- NCT02699827
- Acronym / sponsor ID
- TM1
- Conditions
- Preeclampsia
- Keywords
- Levobupivacaine, Magnesium, Preeclampsia, Epidural
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Mar 2016 (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.
This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS).
Detailed description
Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All patients participating in the study will be randomly divided into two groups; magnesium sulphate group (study group) and placebo group (control group). Patients in the study group will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate 10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml saline 0.9%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate group | Active comparator | Drug: Levobupivacaine hydrochloride, Drug: Magnesium sulphatePatients will receive epidural levobupivacaine hydrochloride + magnesium sulphate |
| Placebo group | Placebo comparator | Drug: Levobupivacaine hydrochloride, Drug: Saline 0.9%Patients will receive epidural levobupivacaine hydrochloride + saline 0.9% |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women with preeclampsia undergoing elective CS.
Key exclusion criteria (20 listed)
- Age < 20 or > 35 years.
- Height < 150 or > 180 cm.
- Body mass index (BMI) > 35 kg/m2.
- Active labor.
- Multifetal pregnancy.
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 |
|---|---|---|
| Levobupivacaine hydrochlorideAlso: ChirocainePatients will receive epidural 20 ml levobupivacaine hydrochloride 0.5% | Drug | Magnesium sulphate group, Placebo group |
| Magnesium sulphatePatients will receive epidural 5 ml magnesium sulphate 10% | Drug | Magnesium sulphate group |
| Saline 0.9%Patients will receive epidural 5 ml saline 0.9% | Drug | Placebo group |
Primary outcome
Pain-free period
Time frame: 24 hours after the epidural anesthesia
The time from reaching sensory block to onset of pain
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 6 Jun 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Tamer Elmetwally, Dr principal investigator
Mansoura University
Mohamed S Abdelhafez, Dr study director
Mansoura University
Reem A Elsharkawy, Dr study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine hydrochloride, Magnesium sulphate and Saline 0.9% in people with Preeclampsia, run by Mohamed Sayed Abdelhafez 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 1 inclusion and 20 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 6 Jun 2017. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain-free period (time frame: 24 hours after the epidural anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2017.