Severe Pre-eclampsiaNCT06126068
Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia.
A study testing Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia in people with Severe Pre-eclampsia and Eclampsia, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial summary
Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Severe Pre-eclampsia, Eclampsia
- What is being tested?
- Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jan 2023to 30 Jun 2023
- 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 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with severe preeclampsia
- Pregnant women with eclampsia
- Signing of informed consented to participate in the study.
Who cannot join
- Refusal of consent,
- Gestational age < 28 weeks
- Received magnesium sulphate prior to presentation
- mild preeclampsia
- chronic hypertension in pregnancy
- Medical or Obstetrical complication of pregnancy.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Federal Teaching Hospital, Abakaliki
Abakaliki, Ebonyi State, 480001
About this study
Official title: Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia in a Resource Poor Setting, Southeast Nigeria.
Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.
To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in severe preeclampsia and recurrent fits in eclampsia in a low resource setting.
A prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at the Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Sociodemographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted.
Read the detailed description
Background: Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.
Objectives: To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in patients with severe preeclampsia and recurrent fits in eclampsia in a low resource setting like ours.
Methods: This was a prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at Alex Ekwueme Federal University Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Social demographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted. Data were collated, tabulated and analyzed using the statistical package for social sciences (SPSS) software (version 22, Chicago II, USA)
- Conditions
- Severe Pre-eclampsia, Eclampsia
- Being tested
- Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia
- Keywords
- Pre-eclampsia, Eclampsia, magnesium sulphate
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and EclampsiaDrug
Loading dose magnesium sulfate versus the Pritchard regimen
| Study group | Role | What they receive |
|---|---|---|
| first arm - Loading dose of magnesium sulfate | Active comparator | This arm received Loading dose of magnesium sulfate only. those that developed complication in each arm were managed according to departmental protocol. Receives: Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia |
| 2. Pritchard regimen | Active comparator | This arm received the full dose of magnesium sulfate regimen by Pritchard. those that developed complication in each arm were managed according to departmental protocol also. Receives: Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of convulsions
percentage of fits in severe pre-eclampsia and recurrence of fits in eclampsia
Measured: During the intervention
Secondary outcomes (1)
Drug toxicity
number of neonatal asphyxia, respiratory depression, loss of tendon reflex and cardiac arrest.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pre-eclampsiaStudies 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
- Model description
- Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nwali Matthew Igwe, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126068
- Sponsor's protocol ID
- MSPL2023CT
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia in a Resource Poor Setting, Southeast Nigeria.
- ClinicalTrials.gov ID
- NCT06126068
- Acronym / sponsor ID
- MSPL2023CT
- Conditions
- Severe Pre-eclampsia, Eclampsia
- Keywords
- Pre-eclampsia, Eclampsia, magnesium sulphate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Nov 2023 (actual)
- 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.
Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.
To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in severe preeclampsia and recurrent fits in eclampsia in a low resource setting.
A prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at the Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Sociodemographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted.
Detailed description
Background: Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.
Objectives: To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in patients with severe preeclampsia and recurrent fits in eclampsia in a low resource setting like ours.
Methods: This was a prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at Alex Ekwueme Federal University Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Social demographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted. Data were collated, tabulated and analyzed using the statistical package for social sciences (SPSS) software (version 22, Chicago II, USA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prevention of Eclampsia in severe pre-eclampsia and further fits in Eclampsia.
| Arm | Type | Receives |
|---|---|---|
| first arm - Loading dose of magnesium sulfate | Active comparator | Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and EclampsiaThis arm received Loading dose of magnesium sulfate only. those that developed complication in each arm were managed according to departmental protocol. |
| 2. Pritchard regimen | Active comparator | Drug: Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and EclampsiaThis arm received the full dose of magnesium sulfate regimen by Pritchard. those that developed complication in each arm were managed according to departmental protocol also. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women with severe preeclampsia
- Pregnant women with eclampsia
- Signing of informed consented to participate in the study.
Key exclusion criteria (6 listed)
- Refusal of consent,
- Gestational age < 28 weeks
- Received magnesium sulphate prior to presentation
- mild preeclampsia
- chronic hypertension in 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 |
|---|---|---|
| Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and EclampsiaLoading dose magnesium sulfate versus the Pritchard regimen | Drug | 2. Pritchard regimen, first arm - Loading dose of magnesium sulfate |
Primary outcome
Incidence of convulsions
Time frame: During the intervention
percentage of fits in severe pre-eclampsia and recurrence of fits in eclampsia
1 secondary outcome
Drug toxicity
Time frame: During the intervention
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 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of magnesium sulfate to prevent and stop fits in pre-eclampsia and Eclampsia in people with Severe Pre-eclampsia and Eclampsia, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
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 3 inclusion and 6 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 13 Nov 2023. 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 Nigeria. 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?
Incidence of convulsions (time frame: During the intervention). 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 13 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.